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Sponsored by Kimberly Vaughn, Executive Strategies, Inc. - Your Executive Recruiting Partner Who Delivers · Acusphere (Tewksbury, MA) and Cephalon (Frazer, PA) have amended their license arrangements such that Ecosphere is receiving $1 million in lieu of $15 million in milestones and future royalties. With this payment, Ecosphere says that it has approximately $2.8 million in unaudited cash. The firm expects this will fund operations up to the fourth quarter. The March and November 2008 license agreements between the firms covered oncology applications of Acusphere’s Hydrophobic Drug Delivery System and AI-525, an intravenous formulation of celecoxib. · An FDA panel will review Amgen’s (Thousand Oaks, CA) proposed osteoporosis drug denosumab on August 13. In a posting on the FDA's Web site, the FDA said its reproductive health drugs advisory committee would meet to review denosumab, which would be sold under the proposed brand name of Prolia. An advisory panel review was expected because denosumab is considered a new chemical entity, and the FDA brings all new drugs to advisory panels for review. · Avigen (Alameda, CA) is in talks to sell the company to MediciNova (San Diego, CA) which was at the center of a battle to control Avigen that illustrated the struggles between small biotechs and their hedge fund investors. The five-month fight between Avigen and its major shareholder, Biotechnology Value Fund, culminated in March with the departure of a trio of Avigen leaders and the company’s decision to liquidate. Avigen and MediciNova said that their understanding could give Avigen shareholders net cash liquidation value plus $3 million. Avigen shareholders could elect to receive cash at closing or a convertible security that would be converted into MediciNova stock. · Buffalo’s Women & Children’s Hospital (Buffalo, NY) will be the site of the nation’s first clinical trial on a drug to treat cystic fibrosis. The Cystic Fibrosis Center at the hospital is the first site to begin recruiting patients for the 48-week international clinical trial to test the VX-770 drug developed by Vertex Pharmaceuticals (Cambridge, MA). Cystic fibrosis is a genetic disease that affects approximately 30,000 people in the US and 70,000 people worldwide. Mutations of the cystic fibrosis gene cause life-threatening lung infections. The Buffalo site of the trial, called STRIVE, will enroll people 12 and older who carry a mutation known as G551D in the CF gene. Ultimately, 80 sites will be involved in the trial. Vertex will conduct three different clinical trials as part of the registration program for the drug involving approximately 110 sites. The current study is a phase three trial. VX-770 was discovered as part of a collaboration with Cystic Fibrosis Foundation Therapeutics, the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation. The Foundation has invested more than $320 million in drug research in the biotech industry since 1998. Vertex retains worldwide rights to develop and commercialize the drug, if it gains regulatory approval. · Cel-Sci (Vienna, VA) said it plans to raise $5 million in much-needed funds from an institutional investor. Cel-Sci, which has been hit by the tough economy, said it will use the funds to speed up its work on its swine flu-treating technology and also to validate its $15 million manufacturing facility in Baltimore, where it plans to produce its late-stage head-and-neck cancer-fighting candidate called Multikine. That product has largely been on hold from planned third-phase clinical trials as Cel-Sci waits for funding or a development partner to help carry it forward. The company also applied for a provisional patent on its experimental, early-stage vaccine technology targeting diseases like the swine flu. · Dendreon (Seattle, WA) expects to spend up to $50 million to expand its therapeutic biotechnology-processing facility in Morris Plains, New Jersey. The plant is where a patient's immune cells would be processed to increase the body's ability to fight prostate cancer, before being re-infused into the patient. The final phase, with additional manufacturing clean-room work stations, production-support areas, warehouse, infrastructure and offices, is to be substantially complete by late April. · Genzyme (Cambridge, MA) said it still believes the virus that shut down its biotechnology drug manufacturing plant in Allston came from tainted nutrients received from an outside vendor, raising the possibility that the virus could infect other companies that use the same supplier. Meanwhile, the FDA, which is responsible for inspecting drug manufacturing plants, said it is still investigating the Genzyme shutdown, which is expected to last through July while the plant is decontaminated. The agency hasn’t revealed any steps to prevent the virus from spreading elsewhere. · GlaxoSmithKline has signed a deal with Chroma Therapeutics (UK), giving GSK access to Chroma’s experimental compounds for inflammatory diseases such as rheumatoid arthritis. The move boosts GSK’s early-stage pipeline but will not deliver products to the market for many years as Chroma's inflammation programs have yet to enter clinical development. The two groups said that Chroma had the potential to receive in excess of $1 billion in total milestone and option payments from GSK if all four small-molecule programs covered by the agreement were successful. Chroma will receive a significant upfront cash payment and GSK will also invest in its $25 million Series D equity financing. · Leaders at the University of Maryland Baltimore BioPark are courting French biotechnology executives looking for a spot along the East Coast to open a new US office. Such a partnership could lead to new lease deals and research collaborations between UMB scientists and their counterparts in Europe. The west-side biotech park hosted more than a dozen executives this month from a region known as Lyonbiopole in Southeast France. The region is home to more than 70 biotech companies. And so far, at least one French company is looking at the biopark as a possible site for its US subsidiary. The UMB BioPark tenants include Gliknik, a biotechnology firm that creates drugs for autoimmune diseases and cancer, Alba Therapeutics, which is developing a drug to treat Celiac disease, and Fasgen, a company that develops drugs that target cancer, obesity and diabetes. · A US immunization panel has voted to include a new vaccine for Japanese encephalitis, a mosquito-borne disease, made by Intercell (Austria), in its list of recommended vaccines for US travelers. Intercell said the Advisory Committee on Immunization Practices, or ACIP, which advises the CDC, approved the vaccine for US travelers to Asia, military personnel and others at high risk. The vaccine, called Ixairo, protects against Japanese encephalitis, which affects 30,000 to 50,000 people each year across Asia, killing up to 15,000. Intercell developed the vaccine and Novartis has commercialization rights. The vaccine won FDA approval in March after studies showed the vaccine offered a high level of protection after only two doses. · Merck KGaA (Germany) moved its experimental cancer vaccine Stimuvax into the third and last phase of testing required for regulatory approval to investigate its use against breast cancer. Merck, which co-develops Stimuvax with Oncothyreon (Seattle, WA) said the trial, dubbed STRIDE(a), will involve patients with advanced, inoperable breast cancer. The drug, which is also being tested against lung cancer in Phase III, has been shown to prime the body's immune system to detect and attack cancer cells. Merck is racing with biotech firms including Transgene (France) and Antigenics (Lexington, MA) to bring cancer vaccines to market. While Transgene's TG4010 compound also targets lung tumors, the most common form of cancer, the Dendreon (Seattle, WA) and Antigenics drug candidates are aimed at prostate cancer and brain cancer, respectively. · A small biotechnology company facing possible bankruptcy and liquidation has been awarded a $35 million federal contract to develop a faster way to make vaccines for pandemic influenza. The award of the contract to the Protein Sciences (Meriden, CT) was announced on Tuesday by the Department of Health and Human Services. But only a day earlier, creditors filed a petition in federal bankruptcy court seeking to force Protein Sciences into bankruptcy and liquidation, saying they were owed $11.7 million. Almost all of that money is owed to Emergent BioSolutions (Rockville, MD) which lent Protein Sciences $10 million last year in advance of the pending acquisition of virtually all the assets of Protein Sciences by Emergent. · Osiris Therapeutics (Columbia, MD) said its stem cell candidate Prochymal met safety goals in a Phase II study focusing on pulmonary disease. Still, shares fell after-hours as the drug candidate failed to work more effectively than placebo at improving lung function. Effectiveness was not the goal of the study, which involved 62 patients. Also, the data was taken after six months, while the patients are being followed for two years. In the phase II clinical trial, the drug is being tested as a potential treatment for chronic obstructive pulmonary disease. · Resolvyx Pharmaceuticals (Bedford, MA), developer of anti-inflammatory drugs, has started the first human clinical trial of an oral form of RX-10001, a resolvin therapeutic. Resolvins are naturally occurring small molecules whose task is to defend healthy tissue whenever the body’s immune system responds to infections or injuries, and then resolve inflammation and promote healing after the injury has passed. The resolvin molecules have the potential to treat asthma, atherosclerosis, rheumatoid arthritis and other inflammatory ailments. RX-10001 is a naturally occurring resolvin that is reported to instigate tissue healing. Founded in 2005, Resolvyx has a current technology portfolio that includes over 55 patents and applications. The company also develops anti-inflammatory drugs for ophthalmic disease therapy. Last November, the company conducted a 30-day investigational new drug review for its Rx-10045 treatment for eye disorders, clearing the company to proceed with clinical trials of the drug. · Troubled Targeted Genetics (Seattle, WA) said it is cutting its staff by more than two-thirds to help keep the company running into August. Targeted said it will reduce its head count to 10 to 15 employees by the end of July. The company currently has 46 employees. The firm said it has also continued to pursue a settlement of its Bothell lease obligations and has also entered into discussions to reduce or eliminate its other facility costs. The unabridged version of SN(i)Ps is published by Gaymond International, a U.S.-based life sciences consultancy that assists corporations, government agencies, academic institutions and research institutes with business development, strategic counsel, due diligence, meetings/events, and executive knowledge treks.
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