Press Release.
Researchers say a new type of cancer treatment has produced highly promising results in preliminary drug trials.
Olaparib was given to 19 patients with inherited forms of advanced breast, ovarian and prostate cancers caused by mutations of the BRCA1 and BRCA2 genes.
In 12 of the patients – none of whom had responded to other therapies – tumours shrank or stabilised. The study, led by the Institute of Cancer Research, features in the New England Journal of Medicine.
CASE STUDY
Julian Lewis, 62, was treated with olaparib after being diagnosed with advanced prostate cancer. Within a month or two levels of a key chemical marker of cancer went down to a low level, and have now stayed low for more than two years. In addition, secondary tumours in his bones have almost disappeared. He has experienced minor side-effects, such as stomach discomfort and mild nausea, but he said:
“I hope to carry on with this for as long as possible. Partly the aim is the obvious one of keeping my cancer cells in check, but there’s a broader goal too: to help find out how long this drug can be used safely in other people.”
One of the first patients to be given the treatment is still in remission after two years.
Olaparib – a member of a new class of drug called PARP inhibitors – targets cancer cells, but leaves healthy cells relatively unscathed.
The researchers, working with the pharmaceutical company AstraZeneca, found that patients experienced very few side-effects, and some reported the treatment was “much easier than chemotherapy”.
Researcher Dr Johann de Bono said the drug should now be tested in larger trials. He said: “This drug showed very impressive results in shrinking patients’ tumours. “It’s giving patients who have already tried many conventional treatments long periods of remission, free from the symptoms of cancer or major side-effects.”
Olaparib is the first successful example of a new type of personalised medicine using a technique called “synthetic lethality” – a subtle way of exploiting the body’s own molecular weaknesses for positive effect. In this case the drug takes advantage of the fact that while normal cells have several different ways of repairing damage to their DNA, one of these pathways is disabled by the BRCA mutations in tumour cells. Olaparib blocks one of the repair pathways by shutting down a key enzyme called PARP.
BRCA MUTATIONS
BRCA1 or BRCA2 mutations weaken the cells’ ability to repair DNA damage. They are thought to be responsible for about 5% of breast and ovarian cancers, and about 1- 2% of early onset prostate cancers. Women with a BRCA mutation have a risk of up to 85% on breast cancer, and up to 60% on ovarian cancer
Men with a BRCA mutation have a risk of up to 15% on prostate cancer. This does not affect normal cells because they can call on an alternative repair mechanism, controlled by their healthy BRCA genes. But in tumours cells, where the BRCA pathway is disabled by genetic mutation, there is no alternative repair mechanism, and the cells die.
BBC NEWS | Health | New cancer drug ‘shows promise’
Cancer cells with the BRCA1 or BRCA2 mutations are the first to be shown to be sensitive to PARP inhibitors. But there is evidence that olaparib will also be effective in other cancers with different defects in the repair of DNA.
Professor Stan Kaye, who also worked on the study, said:
“The next step is to test this drug on other more common types of ovarian and breast cancers where we hope it will be just as effective.”
The researchers say the process of drug evaluation and registration may have to be revamped to take consideration of the fact that new generation cancer drugs target specific molecular defects, rather than types of cancer.
Dr Peter Sneddon, of the charity Cancer Research UK, said:
“It is very encouraging to see the development of ‘personalised treatment’, tailored to the requirements of the individual patient, becoming a reality as it offers the opportunity to design new drugs that are truly selective.
Although development of this drug is in its early stages, it is very exciting to see that it has the potential to work when other treatment options have failed.”
Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/2/hi/health/8116790.stm
Published: 2009/06/24 23:09:10 GMT
© BBC MMIX
Press Release.
German Multicenter ALL Study Group Presented Data at the 14th Congress of the European Hematology Association Showing High Response Rate in Patients with Minimal Residual Disease
BERLIN, June 8 /PRNewswire-FirstCall/ — Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, announced that the German Multicenter ALL Study Group (GMALL) presented phase 2 clinical data of the BiTE® antibody blinatumomab (MT103) at the 14th Congress of the European Hematology Association (EHA) in Berlin, Germany, showing a high response rate in acute lymphoblastic leukemia (ALL) patients with minimal residual disease (MRD)(1). Blinatumomab is a novel therapeutic antibody that activates a patient’s T cells to seek out and destroy cancer cells.
The patients included in this phase 2 clinical trial were in complete hematological remission following intense chemotherapy regimens, but retained a detectable level of ALL cancer cells in their bone marrow — so called minimal residual disease (MRD). Various studies have confirmed that ALL patients with MRD following chemotherapy have a significantly worse prognosis than patients without MRD.
The primary endpoint of the phase 2 study is MRD response within four cycles of treatment. MRD response is defined as the elimination of ALL cancer cells in patients with MRD below the limit of detection. The achievement of the primary endpoint requires that at least 22% of 21 patients have an MRD response. Currently, 13 of 16, or 81% of evaluated patients have shown an MRD response, thus qualifying the trial as having met its primary endpoint before the completion of the study. Patients in all subgroups responded to treatment with blinatumomab, including bcr-abl positive patients after failure of treatment with bcr-abl inhibitors, and patients with t(4;11) translocations. Side effects were observed primarily in the first 24 to 48 hours with transient pyrexia and lympho-/leukopenia being the most frequent adverse events.
“Blinatumomab is one of the most active agents the GMALL has tested in the adult ALL consolidation setting,”
said Dr. Ralf Bargou, principal investigator of the trial.
“We are excited about the significant activity of blinatumomab in ALL and the favorable safety profile observed in this study. These results are particularly important for these patients who are in a disease stage with extremely poor prognosis and for which we lack treatment options except for patients eligible for allogenic stem cell transplantations.”
“The ALL interim data showing an MRD response rate above 80% significantly exceeds the rate which was considered to be clinically meaningful and was set as the hurdle for the achievement of the primary end point,”
said Micromet’s Senior Vice President and Chief Medical Officer, Carsten Reinhardt, M.D.
“We are now looking forward to discussing a pivotal ALL program with the regulatory authorities later this year.”
(1) Topp, M.S. et al (2009). Blinatumomab (anti-CD19 BiTE®) for targeted therapy of minimal residual disease (MRD) in patients with B precursor acute lymphoblastic leukemia (ALL): Update of an ongoing Phase II study. 14th Congress of the EHA 2009, abstract no. 482
Webcast/Conference Call
Micromet will host a webcast/conference call this morning from 9:00 am to 11:00 am U.S. Eastern time to discuss the blinatumomab data presented at the 14th Congress of the European Hematology Association. The webcast will be available on the company’s website at www.micromet-inc.com. To participate in the conference call, dial 866-543-6403 (U.S.) or 617-213-8896 (international), passcode: 12594792.
A replay of the call will be available from 1:00 pm Eastern Time on June 8, 2009 (7:00 pm Central European Time) through June 15, 2009. The replay number is 888-286-8010 (U.S.) or 617-801-6888 (international), passcode: 67386852.
About Micromet, Inc.
Micromet, Inc. is a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases. Its product development pipeline includes novel antibodies generated with its proprietary BiTE® antibody platform, as well as conventional monoclonal antibodies. BiTE antibodies represent a new class of antibodies that activate the T cells of a patient’s immune system to eliminate cancer cells. Four of Micromet’s antibodies are currently in clinical trials. Its BiTE antibody blinatumomab (MT103) is in a phase 2 clinical trial for the treatment of patients with acute lymphoblastic leukemia (ALL), and in a phase 1 clinical trial for the treatment of patients with non-Hodgkin’s lymphoma (NHL). A second BiTE antibody, MT110, is in a phase 1 clinical trial for the treatment of patients with solid tumors. MT110 binds to the epithelial cell adhesion molecule, or EpCAM, which is overexpressed in many solid tumors. Micromet’s human monoclonal antibody adecatumumab (MT201) also binds to EpCAM and is being developed under a collaboration with Merck Serono. Adecatumomab is in a phase 2 clinical trial in colorectal carcinoma patients after complete resection of liver metastases, and a phase 1b clinical trial evaluating adecatumumab in combination with docetaxel for the treatment of patients with metastatic breast cancer. Micromet’s monoclonal antibody MT293, also known as TRC093, is licensed to TRACON Pharmaceuticals, Inc., and is in a phase 1 clinical trial for the treatment of patients with cancer.
In addition, Micromet has established a collaboration with Nycomed for the development and commercialization of MT203, a human antibody neutralizing the activity of granulocyte/macrophage colony stimulating factor (GM-CSF), which has potential applications in the treatment of various inflammatory and autoimmune diseases, such as rheumatoid arthritis, psoriasis, or multiple sclerosis. Nycomed has filed a clinical trial application and is expected to commence a phase 1 clinical trial of MT203 in the first half of 2009. Micromet’s licensee Morphotek, a wholly-owned subsidiary of Eisai, is also expected to initiate a first phase 1 clinical trial with Micromet’s glycolipid-binding human antibody MT228 for the treatment of melanoma. Micromet also has entered into an option, collaboration and license agreement with Bayer Schering Pharma AG under which Bayer Schering Pharma was granted an exclusive option to license a specified BiTE antibody against an undisclosed solid tumor target.
Micromet’s preclinical product pipeline includes several novel BiTE antibodies generated with its proprietary BiTE antibody platform technology. BiTE antibodies targeting CEA, MSCP, CD33, HER2, EGFR and other targets are in various stages of preclinical development.
Forward-Looking Statements
This release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. These forward-looking statements include statements regarding the efficacy, safety and intended utilization of blinatumomab and other product candidates, the conduct, timing and results of future clinical trials, and expectations of the future expansion of our product pipeline and collaborations. You are urged to consider statements that include the words “ongoing,” “may,” “will,” “believes,” “potential,” “expects,” “plans,” “anticipates,” “intends,” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include the risk that product candidates that appeared promising in early research, preclinical studies or clinical trials do not demonstrate safety and/or efficacy in subsequent clinical trials, the risk that encouraging results from early research, preclinical studies or clinical trials may not be confirmed upon further analysis of the detailed results of such research, preclinical study or clinical trial, the risk that additional information relating to the safety, efficacy or tolerability of our product candidates may be discovered upon further analysis of preclinical or clinical trial data, the risk that we or our collaborators will not obtain approval to market our product candidates, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborators, including MedImmune, Merck Serono, TRACON and Nycomed, for the funding or conduct of further development and commercialization activities relating to our product candidates. These factors and others are more fully discussed in Micromet’s Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2009, filed with the SEC on May 11, 2009, as well as other filings by the company with the SEC.
CONTACT:
US Media, Andrea tenBroek or Chris Stamm, +1-781-684-0770, micromet@schwartz-pr.com; European Media, Ludger Wess, +49 (40) 8816 5964, ludger@akampion.com; US Investors, Susan Noonan, +1-212-966-3650, susan@sanoonan.com; European Investors, Ines-Regina Buth, +49 (30) 2363 2768, ines@akampion.com, all for Micromet, Inc.
Press Release.
WALTHAM, Mass.–(BUSINESS WIRE)– Avila Therapeutics, an emerging biopharmaceutical company developing a revolutionary new class of medicines known as covalent drugs, announced today that Katrine S. Bosley has been appointed as Chief Executive Officer. Ms. Bosley is a biotechnology executive experienced in corporate development of emerging and established biopharmaceutical companies and joins Avila as it advances its business strategy, product pipeline, and proprietary platform.
“Avila’s focus on the design and development of covalent drugs is an area that has been only modestly explored by traditional pharmaceutical companies. This has given us a very broad set of unique product opportunities,”
commented Katrine Bosley, Chief Executive Officer.
“We’ve shown with our lead programs that we can deliver products with novel pharmacologic profiles that have the potential to provide unprecedented therapeutic benefits for patients. Furthermore, our strong investor base and experienced leadership team bring to bear the resources and expertise necessary to successfully advance our pipeline.”
Ms. Bosley joins Avila from Adnexus where she served as Vice President, Business Development and later as VP, Strategic Operations, establishing an alliance with and subsequent acquisition by Bristol-Myers Squibb. During her career she has worked with products from discovery through commercialization, including Avonex®, Tysabri®, and the emerging Adnectin™ class of targeted biologics. Ms. Bosley was at Biogen Idec for many years where she held leadership roles in business development, commercial operations, and portfolio strategy in both the U.S. and Europe. She also held positions at Highland Capital Partners, a venture capital firm, and Alkermes, a drug delivery company. Ms. Bosley is a graduate of Cornell University.
About Avila Therapeutics
Avila Therapeutics is developing a new therapeutic approach called ‘protein silencing’ based on a proprietary platform for developing covalent drugs that strongly and resiliently bond to disease-causing proteins, resulting in drugs that can be highly effective.
Avila’s covalent drugs have the potential to deliver unique therapeutic benefits because they are highly targeted, are effective against mutations, and have long duration of action. Avila is developing a pipeline of novel, protein silencing drugs with a current focus on viral infection, cancer, and autoimmune diseases. Avila is funded by four leading venture capital firms: Abingworth, Advent Venture Partners, Atlas Ventures, and Polaris Venture Partners. For additional information, please visit http://www.avilatx.com.
Source: Avila Therapeutics
View this news release online at:
http://www.businesswire.com/news/home/20090515005123/en
Press Release.
Martinsried/Munich, 29. April 2009. MediGene AG (Frankfurt: MDG, Prime Standard, TecDAX) announced today that Dr. Peter Heinrich, Chief Executive Officer, has resigned from his position as member of the Executive Board with immediate effect. The Supervisory Board has accepted the resignation with great regret.
” On behalf of the MediGene Supervisory Board, I would like to thank Dr Peter Heinrich for his long time and successful leadership as Chief Executive Officer of the company. As a co-founder, he essentially shaped the company from the beginning. Due to his entrepreneurial achievements, MediGene today is an internationally acknowledged biotech company with subsidiaries in the UK and the USA and is listed in the German stock index TecDAX. The supervisory Board expresses its heartfelt thankfulness for his achievements and wishes him all the best for his future path of life”
says Prof Dr Ernst-Ludwig Winnacker, Chairman of the Supervisory Board of MediGene AG.
As successor, Dr. Frank Mathias has been appointed by the Supervisory Board. He has joined MediGene a year ago as Chief Operating Officer and Executive Board Member for Marketing, Sales and Business Development and has been responsible for the ongoing partnering process for the cancer drug candidate EndoTAG-1. The pharmacist with PhD has around 20 years’ experience in the pharma and biotech industry, among others as General Manager of Amgen GmbH, the German subsidiary of one of the world-leading biotechnology company Amgen Inc.
Dr. Mathias studied pharmacy at Paris VI University, taking his PhD in 1991. He embarked on his career in industry in 1988 as International Product Manager with Hoechst AG, Frankfurt, then in 1990 joined Albert-Roussel Pharma GmbH in Wiesbaden, first as a Pharmaceuticals Officer, then as a Product Group Manager and as Deputy Head of Marketing. In 1995 Dr. Mathias launched the Anti-Infectives Marketing Department at Hoechst Pharma in Frankfurt before moving as Head of Marketing to Servier Deutschland GmbH in Munich and taking over as General Manager there in 1996. In 2002 he moved as Head of Marketing to Amgen GmbH, Munich, the company he led successfully as General Manager since 2003. In April 2008, he joined the Executive Board of MediGene AG.
“I would like to express my thanks for the trust put in me by to the Supervisory Board. I accept the new challenge with great pleasure and a deep confidence that MediGene AG will continue to develop successfully. MediGene has an excellent team of employees and I look very much forward to working with them furthermore”
says Dr Frank Mathias, the new Chief Executive Officer of MediGene AG.
This press release contains forward-looking statements that involve risks and uncertainties. The forward-looking statements contained herein represent the judgment of MediGene as of the date of this release. These forward-looking statements are no guarantees for future performance, and the forward-looking events discussed in this press release may not occur. MediGene disclaims any intent or obligation to update any of these forward-looking statements. MediGeneTM is a trademark of MediGene AG. This trademark may be held or licensed for specific countries.
MediGene AG is a publicly listed (Frankfurt: MDG, Prime Standard, TecDAX) biotechnology company located in Martinsried/Munich, Germany, with subsidiaries in Oxford, UK and San Diego, USA. MediGene is the first German biotech company to have drugs on the market, which are being distributed by partner companies and has several drug candidates in clinical development, two of which provide significant sales potential. In addition, the company has numerous projects in research and pre-clinical development and possesses innovative platform technologies. MediGene focuses on the research and development of novel drugs for the treatment of cancer and autoimmune diseases.
Contact MediGene AG
E-mail: investor@medigene.com
Fax: +49 – 89 – 85 65 – 2920
Julia Hofmann / Dr. Nadja Wolf,
Public Relations,
Tel.: +49 – 89 – 85 65 – 3324
Dr. Georg Dönges,
Investor Relations,
Tel.: +49 – 89 – 85 65 – 2946
Press Release.
Avila Therapeutics emerged from stealth mode in December and told Xconomy about its secret sauce to systematically create permanent, covalent bonds with protein disease targets. Now the Waltham, MA-based biotech (pronounced AH-vill-uh) reports that its experimental drug for hepatitis C virus may be able to wipe out multiple variations and mutated forms of the virus.
The firm’s drug, dubbed AVL-181, is a small molecule protease inhibitor intended to silence a key protein for the survival and replication of the virus. The drug targets a region of the protein that the company believes is common among many known forms of the virus, even those that are resistant to standard treatments, meaning that the firm may have found an “Achilles’ heel” of the protein, says Nagesh Mahanthappa, vice president of business development and operations at the biotech. Over the weekend, the company presented results of a study, in which infected mice were treated with the drug, at the European Association for the Study of the Liver meeting in Copenhagen, Denmark.
“When we look across all known published genetic sequences of the hepatitis C protease, from a variety of mutants, we find that the particular site where we get bond formation with our drug is constant,” Mahanthappa says. “It remains possible that that site is somehow critical for the protease’s normal function, or the general fitness of the virus.”
It’s early in the game to draw any conclusions about Avila’s hepatitis C drug, which to date hasn’t yet advanced to clinical trials. Yet the fact that the startup may have found a new weakness in the virus, making the drug effective across drug-resistant and mutated strains, could help the drug stand out among the 40-odd other hepatitis C treatments in development. With industry embracing a cocktail approach to treating the disease, Mahanthappa says, there’s a possibility that Avila’s drug could be useful in combination with other drugs to combat difficult-to-treat variations of hepatitis C, which is a chronic liver disease that affects 170 million people worldwide.
The study presented over the weekend showed several potential benefits of Avila’s hepatitis C drug over existing treatments. For one, it had no significant impact on other proteins, boding well for how safe the drug could be for humans. Another potential perk is that the drug appears to work for 24 hours or more, meaning it could be taken once a day rather than several times a day. Yet there were many new hepatitis C drugs presented at the medical conference and most of the companies presenting those other drugs promised improvements over existing therapies as well. Cambridge, MA-based Vertex Pharmaceuticals (NASDAQ: VRTX) is generally considered the front-runner in the race to develop the first protease inhibitor for hepatitis C, called telaprevir. That drug is now in the third and final stage of clinical trials needed before it can win FDA approval to start selling in the U.S.
For Avila, the hepatitis C protease inhibitor is one of two drugs that are neck and neck for top position in the biotech’s young pipeline, Mahanthappa says. The other, called AVL-291, is a small molecule kinase inhibitor that could be used to treat immune system cancers such as non-Hodgkin’s lymphoma and B cell chronic lymphocytic leukemia. The company’s earlier plan was to begin human clinical trials of its hepatitis C drug by late 2009, but Mahanthappa says that the company now wants to wait until mid-2010 to start its first clinical trial. The company also hasn’t decided which of its drugs to enter into clinical trials first. The reason for waiting an extra half year to begin clinical trials is to make the firm’s existing capital last longer. The firm wants to raise more venture capital before it launches an initial clinical trial and—in case you’ve been living under a rock and don’t know—the climate nowadays for completing such financings is pretty awful.
Avila is now in the midst of raising another round of financing, Mahanthappa says. The firm has previously recieved $21 million in venture capital from lead investor Abingworth Management as well as Polaris Venture Partners, Atlas Venture, and Advent Venture Partners.
Press Release.
London, December 18, 2008. Advent Venture Partners (‘Advent Ventures’) today announces the sale of one of its portfolio companies, Thiakis, to Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE) for a total consideration of £100 million which includes upfront and clinical development milestone payments. Thiakis’s lead product candidate, TKS1225, is an analogue of the peptide hormone oxyntomodulin being studied for the treatment of obesity and the prevention and amelioration of associated conditions such as Type 2 diabetes and cardiovascular diseases.
Thiakis was founded in 2004 by Professor Stephen Bloom who is a world leading expert in the study of metabolic diseases at Imperial College, London, and by Dr John Burt who served as Chief Executive Officer, with support from Imperial Innovations (AIM: IVO).
Advent Venture Partners co-led the Series ‘A’ financing round for the company in 2006 along with Novo A\S and Imperial Innovations and co-investment from Royal Society, Esperante and others. Advent Ventures’ General Partner, Dr Raj Parekh, served on the Board.
Thiakis and its investors were advised by Credit Suisse, Morrison & Foerster and Rawlinson & Hunter.
About Advent Ventures:
Advent Ventures is one of the most experienced venture capital firms in the UK. Established in 1981 it invests in both the Life Sciences and the Technology sectors. It has over £500 million (US$ 765 million) under management from institutional investors across Europe and the USA. It has backed around 60 life science companies of which, to date, 22 have obtained public listings and a further 10 companies have been sold including PowderMed (to Pfizer) and KuDOS Pharmaceuticals (to AstraZeneca). Recent public listings include Amsterdam Molecular Therapeutics on Euronext Amsterdam. Recent investments by the Advent Ventures Life Sciences team include the Swiss therapeutic antibody company, 4-Antibody; UK medical device company, Starbridge Systems; and EUSA Pharma, a transatlantic specialty pharmaceutical company.
For further information please contact:
Francesca Reville
Penrose Financial
Tel 020 7786 4884
Dr Raj Parekh
Advent Venture Partners
Tel 020 7932 2100
Press Release.
Infinity Announces Global Strategic Alliance With Purdue Pharma and Mundipharma Encompassing Infinity’s Early Clinical and Discovery Programs
Infinity Retains All U.S. Rights; Mundipharma Receives Ex-U.S.
Commercialization Rights to All Oncology Products Under Alliance.
Infinity to Receive Up to $75 Million Equity Investment, Access to $50 Million Line of Credit, and Significant R&D Funding Over Multiple Years.
Conference Call Being Held At 8:30 a.m. EST Today to Discuss Transaction.
CAMBRIDGE, Mass., Nov. 20, 2008 (GLOBE NEWSWIRE) –Infinity Pharmaceuticals, Inc. (Nasdaq:INFI) today announced that it has entered into a global strategic alliance with Purdue Pharmaceutical Products L.P. and Mundipharma International Corporation Limited, focused on the research, development, and commercialization of Infinity’s early clinical and discovery programs, including IPI-926, Infinity’s novel inhibitor of the Hedgehog signaling pathway. Infinity expects that this alliance will enable it to aggressively pursue its goal of developing and commercializing its pipeline of innovative anti-cancer agents.
“Infinity’s mission is to discover, develop, and deliver to patients important medicines for the treatment of cancer,”
said Steven
H. Holtzman, chair and chief executive officer of Infinity.
“This alliance with Purdue Pharma and Mundipharma provides Infinity with the financial resources and independence to continue our productive discovery efforts, to expand our clinical development capabilities, and to build our own organization to commercialize our products in the United States. In a nutshell, we have the opportunity to realize all aspects of our mission in a manner that we believe will create meaningful treatments for patients and meaningful value for our shareholders.”
“Purdue U.S., Purdue Canada, and Mundipharma companies in Europe and Asia have been expanding their therapeutic scope significantly in recent years,”
said Jim Dolan, Senior Vice President of Licensing and Business Development for Purdue.
“Mundipharma’s presence in oncology outside of the U.S. is now well-established, and we expect that the broad alliance with Infinity will give us the opportunity to bring to market a number of innovative, best-in-class treatments for cancer patients. In addition, this alliance will also build upon our core franchise in pain on a global basis, with FAAH, a potentially innovative new product for neuropathic pain.”
The alliance will focus on the advancement of Infinity’s early-stage clinical and discovery pipeline of novel, small molecule drug candidates. This pipeline includes IPI-926, Infinity’s potent inhibitor of the Hedgehog pathway. IPI-926 is being evaluated in a Phase 1 clinical study in patients with advanced solid tumors and has demonstrated significant anti-tumor activity in a number of preclinical models. Infinity’s pipeline also includes several earlier stage discovery programs, including a program directed to fatty acid amide hydrolase (FAAH), an emerging target for the treatment of neuropathic pain.
Infinity’s Hsp90 inhibitor program, comprising IPI-504 (retaspimycin hydrochloride), which is in an international Phase 3 registration trial for patients with refractory gastrointestinal stromal tumors (the RING trial), and IPI-493, Infinity’s oral candidate currently in a Phase 1 study in patients with advanced solid tumors, remains partnered with AstraZeneca and is excluded from this alliance. Infinity’s program targeting the Bcl family of proteins, which was transitioned to Novartis in February of 2008, is also excluded from this alliance.
“This relationship provides an incredible opportunity for Infinity by affording us access to the capital necessary to do what our R&D team does best: to discover and develop important new medicines for patients,”
said Adelene Q. Perkins, president and chief business officer of Infinity.
“It enables us to continue to operate nimbly while building upon and enhancing our culture of citizen ownership that we hold so dear.”
Details of the Transaction
Infinity Pharmaceuticals, Inc. has entered into a strategic alliance agreement with Mundipharma International Corporation Limited to develop and jointly commercialize pharmaceutical products. Under the terms of the strategic alliance agreements, Infinity will retain U.S. commercialization rights for all oncology products developed under these programs. Infinity is obligated to pay Mundipharma a royalty on U.S. sales of these products. Mundipharma has the right to commercialize these products outside of the United States, and is obligated to pay a royalty to Infinity on sales outside of the U.S. Infinity will direct and lead all oncology discovery and development efforts on a worldwide basis.
Purdue has made an equity investment of $45 million in Infinity through the purchase of four million shares of Infinity common stock at $11.25 per share, a 112% premium over the closing price of $5.29 on November 19, 2008. Subject to Infinity shareholder approval and other customary closing conditions, these entities have agreed to invest an additional $30 million in Infinity to purchase two million shares of Infinity common stock and warrants to purchase up to six million additional shares of Infinity common stock. The warrants may be exercised between the second closing date (expected to occur in January 2009) and June 30, 2012 at prices ranging from $15 to $40 per share.
In addition, upon the second closing, Purdue will make available to Infinity a $50 million line of credit for use by Infinity for any business purpose, with principal and accrued interest to be repaid by the tenth anniversary of the second closing.
Under the alliance, Mundipharma will participate in Infinity’s Hedgehog program as well as new Infinity discovery and development programs (subject to certain opt-out rights outlined below) for three years, with an ability to extend this right for two additional one-year terms. Mundipharma will fund the costs of these programs until the later of the start of the first Phase 3 trial for the program or December 31, 2013. If a program commences Phase 3 studies after December 31, 2013, Infinity and Mundipharma will share the costs of development equally.
The alliance will also encompass Infinity’s discovery program directed to FAAH. Purdue and Mundipharma will have the right to assume development of the FAAH program at the conclusion of Phase 1 clinical studies by funding the research and development costs of the program through approval and paying a royalty to Infinity on global net sales.
Finally, under the alliance, Infinity grants to Mundipharma an option, on set terms, to participate in programs that Infinity may in-license during the term. Mundipharma will have the right to opt-out of development of any particular program on an annual basis, with the first opt-out right becoming available in July 2009 for the Hedgehog and FAAH programs. If Mundipharma elects to opt-out of a program, it will be obligated to continue funding that program for an additional year, and have the right to receive royalties on future sales based on the stage of development of the program when the election to opt-out took place.
Conference Call and Webcast Information
Infinity management will hold a conference call to discuss the transaction today, Thursday, November 20, 2008 at 8:30 a.m. EST. Callers may participate in the call by dialing 1-877-419-6598 (domestic) or 1-719-325-4916 (international) five minutes prior to the start time. An archived version of the webcast will be available in the Investors/Media section of Infinity’s website at http://www.infi.com beginning by 5:00 p.m. EST on Thursday, November 20, 2008 through 5:00 p.m. EST on Wednesday, December 3, 2008.
Important Additional Information Will Be Filed with the SEC
Infinity plans to file with the United States Securities and Exchange Commission (SEC) and mail to its stockholders a proxy statement in connection with the transaction. The proxy statement will contain important information about Infinity, the transaction, and related matters. Investors and security holders are urged to read the proxy statement carefully when it is available.
Investors and security holders will be able to obtain free copies of the proxy statement and other documents filed with the SEC by Infinity through the website maintained by the SEC at www.sec.gov. In addition, investors and security holders will be able to obtain free copies of the proxy statement from Infinity by contacting Monique Allaire at Monique.Allaire@infi.com or 617-4531015.
Infinity and its directors and executive officers may be deemed to be participants in the solicitation of proxies in respect of the transaction described herein. Information regarding Infinity’s directors and executive officers is contained in Infinity’s Annual Report on Form 10-K for the year ended December 31, 2007 and its proxy statement dated April 10, 2008, which are filed with the SEC. As of October 31, 2008, Infinity’s directors and executive officers beneficially owned approximately 4,886,372 shares, or approximately 24 percent, of Infinity’s common stock. A more complete description will be available in the proxy statement.
About IPI-926
IPI-926 is a novel, proprietary inhibitor of the Hedgehog signaling pathway being evaluated in a Phase 1 clinical trial in patients with advanced solid tumors. IPI-926 is a derivative of the natural product cyclopamine that binds to and inhibits a key regulator of this pathway, the Smoothened receptor. The Hedgehog signaling pathway is normally active in regulating tissue and organ formation during embryonic development. However, abnormal activation of the Hedgehog pathway can lead to cancer and is believed to play a central role in allowing the proliferation and survival of several types of cancers, including pancreatic, prostate, lung, breast, and certain brain cancers. In preclinical models, IPI-926 has demonstrated significant anti-tumor activity and excellent pharmaceutical properties, including oral bioavailability, long plasma and tumor half-life, and dose-dependent inhibition of tumor growth, in a number of preclinical models.
About Fatty Acid Amide Hydrolase (FAAH)
Fatty acid amide hydrolase (FAAH) is an emerging target for the treatment of neuropathic pain. The enzyme FAAH degrades anandamide, which is an endogenous cannabinoid that produces an analgesic effect in response to pain. FAAH inhibition increases the duration of anandamide’s analgesic effect, prolonging pain relief at the site of release. Infinity’s FAAH inhibitor program is in lead optimization; the company expects to select a clinical candidate by early 2009.
About Infinity Pharmaceuticals, Inc.
Infinity is an innovative cancer drug discovery and development company seeking to discover, develop, and deliver to patients best-in-class medicines for the treatment of cancer and related conditions. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging cancer pathways. Infinity’s two most advanced programs in Hsp90 inhibition and Hedgehog signaling pathway inhibition are evidence of its innovative approach to oncology drug discovery and development. For more information on Infinity, please refer to the company’s website at http://www.infi.com.
Safe Harbor For Forward-Looking Statements
Statements in this press release regarding the proposed transaction between Infinity and Purdue Pharmaceutical Products L.P. and Mundipharma International Corporation Limited, including, without limitation, the expected timetable for completing the transaction, the expected financial and operational benefits of the transaction, Infinity’s estimate of research and development payments to be made by Mundipharma over the next five years, the availability of the line of credit and any other statements about the parties’ future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “anticipates,” “expects,” “may,” “will,” “would,” “intends,” “estimates” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: For example, there can be no guarantee that the strategic alliance will continue for its full term or that Purdue and Mundipharma will continue to fund Infinity’s programs as agreed; that the parties will successfully discover, develop or commercialize products under the alliance; or that Infinity will satisfy the conditions to the closing of the second equity investment, including obtaining the necessary stockholder approval and clearance under the Hart-Scott-Rodino Act. In particular, Infinity’s management’s expectations could be affected by risks and uncertainties relating to a failure of stockholders to approve the second equity investment; a failure of Infinity and/or Mundipharma to fully perform under the alliance agreement and/or an early termination of the alliance agreement; results of clinical trials and preclinical studies that are the subject of the strategic alliance, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. Food & Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites, and publication review bodies; Infinity’s ability to enroll patients in its clinical trials; unplanned cash requirements and expenditures; Infinity’s ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates it is developing; and the other factors described in Infinity’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2008, as filed with the SEC on November 5, 2008, and other filings that Infinity makes with the SEC from time to time. Infinity disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
CONTACT:
Infinity Pharmaceuticals, Inc.
Investors
Monique Allaire
Monique.Allaire@infi.com
www.infi.com
Pure Communications, Inc.
Media
Sheryl Seapy
949-608-0841
Sheryl@purecommunicationsinc.com
(C) Copyright 2008 GlobeNewswire, Inc. All rights reserved.
Press Release.
Second Round of Funding Supports Commercialization of Recently FDA-cleared Pathwork® Tissue of Origin Test
SUNNYVALE, Calif. — Pathwork Diagnostics, a molecular diagnostics company focused on oncology, announced the closing today of a $20 million financing led by Abingworth. The announcement came on the heels of FDA’s clearance for the Pathwork® Tissue of Origin Test for diagnosis of tumors of uncertain origin, including poorly differentiated, undifferentiated and metastatic tumors.
”With this $20 million round of financing completed and the recent FDA clearance, the company is well positioned to fund important commercialization programs, including offering the Pathwork Tissue of Origin Test through an additional distribution channel, and building our pipeline,”
said Deborah J. Neff, President and Chief Executive Officer of Pathwork Diagnostics.
In addition to offering the Pathwork Tissue of Origin Test as a service through the CLIA-certified Pathwork Diagnostics Laboratory, FDA clearance of the in vitro diagnostic (IVD) kit version of the test will give Pathwork’s customers the opportunity to purchase an IVD kit and run the test in their own labs.
“Our channels to market are expanding and we are building our customer support team to provide outstanding service to our customers,” said Neff. “In addition, we are investigating new applications of our technology that will enable us to offer new, breakthrough diagnostic capabilities to the oncology community.”
Pathwork’s lead investor, Abingworth, based in London and with local offices in Menlo Park, Calif., specializes in the life sciences and healthcare industries.
“We are delighted to become an investor in this unique company,” said Ken Haas, Venture Partner with Abingworth. “Molecular diagnostics is already making a significant difference in the care of cancer patients and Pathwork, with its combination of a novel and proprietary approach, a validated test available through two commercial channels and a broadly applicable platform, is poised to be a leader in this field.”
Abingworth joins the existing investors participating in this round, including Prospect Venture Partners, Advent Venture Partners, Novus Ventures, Venrock and Versant Ventures.
“Completing this successful financing in the current economy, with well-respected investment firms is a strong vote of confidence in our technology and commercialization strategy”
said Neff.
About Pathwork Diagnostics
Pathwork Diagnostics, Inc., based in Sunnyvale, Calif., develops and commercializes high-value molecular diagnostics for oncology. The company delivers FDA-cleared, microarray-based tests to clinical laboratories and also provides diagnostic tests through its CLIA-certified laboratory. The company’s initial tests utilize Pathwork Diagnostics’ proprietary analytics and a companion Pathchip® microarray, which runs on the proven Affymetrix GeneChip® System. The company’s first test – the Pathwork Tissue of Origin Test – is now FDA-cleared as an in vitro diagnostic kit. A functionally equivalent version of the test is also available through Pathwork® Diagnostics Laboratory. The test aids in determining a tumor’s origin so that standard-of-care, cancer-specific treatment can begin. For more information, please call toll-free 1.877.808.0006 or visit www.pathworkdx.com.
© 2008 Pathwork Diagnostics, Inc. All rights reserved. Pathwork, Pathchip, Pathwork Diagnostics, and the Pathwork Diagnostics logo are trademarks or registered trademarks of Pathwork Diagnostics, Inc. Other names may be the trademarks of their respective owners.
Press Release.
Oslo, Norway, 28 August 2008 – Algeta ASA (OSE: ALGETA), the Norwegian cancer therapeutics company, today announced that the primary objective of its BC1-03 Phase II pain palliation study was met. The study showed that even single doses of Alpharadin in patients with painful bone metastases could produce increasing clinical benefit with increasing dose. Pain palliation is an important quality of life benefit in metastatic cancer patients. The trial also confirmed Alpharadin’s benign side-effect profile and, importantly for a drug in this clinical setting, no significant bone marrow toxicity was observed.
In men with HRPC life expectancy can be as short as 18 months, and it is estimated that 100,000 men in the EU and USA die from the disease each year. In 85% of these men the tumor will have spread into the bones. These metastases are a significant problem as they can cause intractable and debilitating pain as well as contributing to a further reduction in life expectancy.
The BC1-03 study was a double-blind randomised pain control study comparing the palliative effects of four different single dose levels of Alpharadin in patients with bony metastatic HRPC. The drug was given by i.v. injection mainly on an outpatient basis. The palliative efficacy of Alpharadin was measured using an assessment of bone pain as well as the patient’s consumption of analgesia. The primary study objective was to investigate whether there was a dose-response relationship with respect to pain palliation in this patient group. The study has shown the beneficial palliative effect of a single dose of Alpharadin and that there is a clear dose-response effect, with higher doses providing better pain relief.
The study also showed a dose-dependent reduction in bone alkaline phosphatase (ALP) ranging from no effect in the lowest dose group to a marked reduction in the higher dose groups. ALP is a severity marker of bony metastatic disease and of prognostic importance.
The study has also further confirmed the safety of Alpharadin and shown its benign side-effect profile. In fact, the higher the dose of Alpharadin that patients received, the fewer adverse events were experienced. This reproduces the safety profile of the earlier BC1-02 Phase II study where the Alpharadin group experienced fewer adverse effects than the placebo comparator group. Importantly for a drug in this clinical setting no significant bone marrow toxicity was observed in patients receiving Alpharadin.
The full results of the BC1-03 study will be submitted for publication in a peer-reviewed journal.
The principal investigator of the study Professor Sten Nilsson at the Karolinska Hospital in Stockholm said:
“These results showing the beneficial impact of Alpharadin in terms of pain palliation are important, as improved quality of life, alongside increased survival, are the two key goals of anti-cancer therapy of patients with skeletal metastases.”
Commenting on today’s further positive news with Alpharadin, Algeta’s President and CEO, Dr. Thomas Ramdahl, said:
“These results build on the positive Phase II clinical data package that we have already assembled with Alpharadin, the highlight of which was the significant survival benefits that we have already reported in patients with HRPC.
Based on our clinical trials to-date I am very confident that Alpharadin has the potential to become an important new therapy for patients with prostate cancer. This view has been reinforced by the enthusiastic and positive response we have received from key opinion leaders around the world to our unique approach to treating HRPC.”
Algeta has recently started enrolling patients for the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) study. This international study will evaluate Algeta’s targeted therapeutic Alpharadin in advanced, hormone-refractory prostate cancer (HRPC) that has metastasized to the skeleton. Approximately 750 patients are expected to be enrolled at more than 125 medical centers in Europe, Asia, South America and Canada. The Coordinating Investigator for the study is Dr. Christopher Parker, a leading clinical oncologist and specialist in prostate cancer, based at the Institute of Cancer Research and the Royal Marsden Hospital in the UK.
For further information, please contact
Dr. Thomas Ramdahl, CEO
Øystein Soug, CFO
+47 23 00 79 90 / +47 913 91 458 (mob)
+47 23 00 79 84 / +47 906 56 525 (mob)
post@algeta.com
For international enquiries:
Dr. Mark Swallow / David Dible
Citigate Dewe Rogerson
+44 (0)207 638 9571
mark.swallow@citigatedr.co.uk
About Algeta
Algeta ASA is a Norwegian cancer therapeutics company built on world-leading, proprietary technology. Algeta is developing new, targeted cancer therapeutics that harness the unique characteristics of alpha particle emitters and are potent, well-tolerated and convenient to use.
Algeta’s lead product candidate, Alpharadin, has commenced an international phase III clinical trial in hormone-refractory prostate cancer (ALSYMPCA) based on positive phase II results. Alpharadin is a novel bone-seeking therapeutic based on the alpha particle emitter radium-223 and may target skeletal metastases from multiple cancer types, as well as primary bone cancers.
Algeta is also developing other technologies for delivering alpha emitters. These include microparticles, liposomes, and methods to enhance the potency of therapeutic antibodies and other tumor-targeting molecules by linking them to the alpha particle emitter thorium-227. The Company is headquartered in Oslo, Norway, and was founded in 1997. Algeta listed on the Oslo Stock Exchange in March 2007 (Ticker: ALGETA).
Alpharadin and Algeta are trademarks of Algeta ASA.
Forward-looking Statement:
This news release contains forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on results of operations and the financial condition of Algeta. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Theses factors include, among other things, risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the risk of non-approval of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products.
