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Sponsored by Kimberly Vaughn, Executive Strategies, Inc. - Your Executive Recruiting Partner Who Delivers • Adventrx Pharmaceuticals (San Diego, CA) said it intends to submit its experimental chemotherapy drug ANX-530 to the FDA before the end of the year. The specialty pharmaceutical company indicated in December it would seek a partner to help push its drug forward, until an unnamed investor stepped forward in June. The drug, a reformulated version of intravenous chemotherapy drug Navelbine used for treating non-small cell lung cancer, is aimed at reducing the incidence and severity of injection site reactions. Worldwide sales of Navelbine and generic vinorelbine in 2006 were in excess of $200 million. • Alnylam Pharmaceuticals (Cambridge, MA) is collaborating with Tekmira Pharmaceuticals (Vancouver, BC, Canada) to find new cationic lipids and lipid nanoparticles that will improve RNAi therapeutics delivery. The two-year agreement calls for Alnylam to fund the research and retain exclusive rights for inventions stemming from the collaboration. Last month, Alnylam and Novartis announced a plan to add another year to the two companies’ collaboration through October 2010. Their multiyear alliance first began in 2005, with the two companies targeting a goal of developing treatment for disease gene targets outlined by Novartis. • Athersys (Cleveland, OH) is looking for commercial partners to help it develop and test its stem cell and drug therapies aimed at treating a variety of health problems. The company’s stem cell line, called MultiStem, is an off-the-shelf therapy that Athersys is testing as a treatment for heart attack and stroke victims, as well as bone marrow transplant recipients who develop certain disease. Unlike other stem cell therapies that aim to achieve wholesale replacement of damaged tissue, MultiStem exhibits a more drug-like profile in which cells augment healing and exert a benefit in multiple ways, and then are cleared from the body over time. • New US patents for the PKU drug Kuvan will significantly strengthen BioMarin’s (Novato, CA) position. The orphan drug Kuvan is used to bring down phenylalanine levels in patients with the blood disorder phenylketonuria or PKU, which is thought to affect 50,000 patients in the US and Europe. While Kuvan was not BioMarin’s bestseller in the period, it did make a significant contribution to the total $82.8 million revenue of the product sales generated over the three months. • Debiopharm (Switzerland) inked a worldwide, exclusive license agreement for Curis’s (Cambridge, MA) heat shock protein technology. The deal includes CUDC-305, the company's lead Hsp90 inhibitor candidate, which is in preclinical development. An IND application is expected to be filed in fall 2009. • Eiger BioPharmaceuticals (Palo Alto, CA) licensed exclusive worldwide rights to a hepatitis C virus technology developed in the Stanford University (Palo Alto, CA) lab of its founder, Dr. Jeffrey Glenn. Terms of the deal were not disclosed. The company, which earlier this year raised $7.1 million in a Series A financing from InterWest Partners and Vivo Ventures, said the technology could disrupt the virus’ ability to resist certain drugs. Specifically, the technology is aimed at a non-structural protein, called NS4B, which binds to the virus’ RNA and is required to replicate the virus. • Elan (Ireland) has filed suit against Biogen Idec (Cambridge, MA), essentially asking a federal court to determine whether Elan has breached a preexisting marketing agreement between the two companies. The filing comes on the heels of Elan’s announced marketing deal with Johnson & Johnson, which has agreed to help Elan purchase Biogen’s rights to its multiple sclerosis drug Tysabri if Biogen is acquired by another entity. • Genentech (South San Francisco, CA), which is owned by Roche, said the FDA approved its cancer treatment Avastin for a new use against a form of kidney cancer, marking the sixth approval for the blockbuster drug. Avastin is already approved to treat certain types of lung, breast and colon cancer. FDA regulators cleared the injectable treatment for advanced renal cell carcinoma, the most common form of kidney cancer. Roughly, 50,000 new cases of the disease are diagnosed in the US each year, according to the National Cancer Institute. Avastin was Genentech's top-selling product last year with revenue of $2.69 billion. Initially approved in 2004, Avastin was the first drug to fight cancer by choking off blood flow to tumors. Such targeted therapies were considered a significant advance beyond chemotherapy. • Genzyme (Cambridge, MA) said the FDA will re-inspect a Boston facility to determine whether manufacturing issues discovered in February have been fixed. The company said it fixed the manufacturing problems and the plant was re-inspected in May. Separately, in June, Genzyme temporarily shut down the production facility in the Boston neighborhood of Allston to clean up viral contamination that had been slowing down the process for making supplies of two biotech-based drugs. Genzyme (Cambridge, MA) had a welcome bit of news for a change. The drug, which was just granted marketing authorization by the EC, is Mozobil, a new option for patients with the blood cancers lymphoma and multiple myeloma who require an autologous stem cell transplant. Mozobil is already approved for use in the US. • GlaxoSmithKline has signed a deal potentially worth $200 million with Vernalis (UK) to boost its early-stage research in cancer. Vernalis will get $6 million upfront, including a $3 million equity subscription by GSK for a 3.4% stake, and is eligible for much larger payments plus up to double-digit royalties on any sales if the research is successful. The deal represents a significant funding boost for Vernalis. • Canaan Partners has co-led a $7 million, Series C round of venture capital in Liquidia Technologies (Durham, N.C), which uses nanotechnology to improve drug design and delivery. The round brought Liquidia’s total venture haul to $31.5 million since the company was formed in 2004 by a chemistry professor who holds dual appointments at the University of North Carolina (Chapel Hill, NC) and North Carolina State University (Raleigh, NC). In January, Liquidia announced an agreement with Abbott Laboratories that grants a license to use Liquidia’s technology to create nanoparticles sized and shaped to precisely deliver Abbott’s therapies to specific cancer cells. The company has been doing its own research and development on vaccines and inhaled therapies. The company is now in the final stages of identifying a vaccine candidate. • Novavax (Rockville, MD) said it created a version of the swine flu virus for use in a potential vaccine. Using a gene sequence provided by the CDC, Novavax said it produced a virus-like particle, which is similar to particles of swine flu but does not have the genes necessary to replicate. The company said it developed the virus-like particle 11 weeks after getting the gene sequence. • OncoGenex Pharmaceuticals (Bothell, WA) was so obscure at one point last year that zero shares changed hands one day, but it has suddenly morphed into one of the surprise biotech success stories of 2009. A few weeks ago, when the company decided to raise some money to give it a little more cash cushion while it was negotiating with partners, it could have easily raised $50 million or more, but it only took $9.5 million. Instead of hiring an underwriter to pitch the shares, it just started personally calling institutional investors one. OncoGenex stock was that easy for a reason. Researchers reported the company’s experimental prostate cancer drug, OGX-011, was able to help men live longer than standard chemotherapy in a clinical trial of 82 patients. • Purdue Pharmaceutical Products (Stamford, CT) has worked up an exclusive license and collaboration agreement with Transcept Pharmaceuticals (Port Richmond, CA) to commercialize the sleep drug Intermezzo in the US, in a deal worth up to $145 million to Transcept. The terms of the deal calls for Purdue to pay Transcept $25 million in upfront cash and an additional payment of up to $30 million based upon the timing of approval of Intermezzo by the FDA. Transcept could then get up to an additional $90 million upon reaching future milestones. Intermezzo would be the first prescription sleep aid intended to be used in the middle of the night at the time a patient awakens and has difficulty returning to sleep, if approved by the FDA. Transcept has kept hold of an option to co-promote Intermezzo to psychiatrists in the US and has retained rights to commercialize Intermezzo in the rest of the world.
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