| This week's sponsor is Rules-Based Medicine. |  |
Today's Top Stories
1. Seattle Genetics takes step closer with FDA review of lymphoma drug
2. Pfizer, J&J's Alzheimer's drug might get boost from FDA trial rules
3. BioSante's female sexual dysfunction drug draws partnering interest
4. Durect, Zogenix in deal for drug that could rival major J&J treatment
5. Tarsa Therapeutics adds to $24.5M financing, advances osteoporosis drug Also Noted: Novella Clinical
Spotlight On... Key R&D programs moving biotech stocks
Biotech VCs topped tech peers; AMAG Pharmaceuticals rebounds from FDA safety setback; and much more... More Fierce Life Sciences News:
1. New gonorrhea strain resistant to all available antibiotics
2. Metamark finds proteins that predict melanoma spread
3. Gilead first to jump into AIDS patent pool
Today's Top News 1. Seattle Genetics takes step closer with FDA review of lymphoma drug
The folks at Seattle Genetics ($SGEN) might rest a bit easier tonight heading into an advisory committee meeting that will consider its experimental lymphoma drug later this week. An FDA staff review of the firm's drug, brentuximab vedotin, or Adcetris, appears to have produced no unexpected red flags. Yet the review did raise the question of whether the small trials completed for the drug to date offer enough evidence of its benefits. "Small size limits the benefit-risk analysis," the FDA said in its review, as cited by Bloomberg this morning. "For this application, consideration for accelerated approval would be consistent with regulatory actions taken in the past decade for similar hematology applications based on single arm clinical trials." With some exceptional results in small trials of the drug--which is an antibody linked to an anti-cancer toxin--many people across the biotech industry are closely watching how reviews of the treatment go this week. The FDA staff review noted safety issues in patients treated with the drug such as peripheral neuropathy, infections and a type of suppression to the immune system--but not much there that hadn't already been revealed about the drug's safety profile or what was expected from the review. The next big test for Seattle Genetics' drug comes on Thursday, when an advisory committee of experts will weigh in on the firm's application to gain approval to market the drug as a treatment for Hodgkin lymphoma and anaplastic large cell lymphoma. If the panel recommends approval, that would be a key endorsement of its application ahead of the FDA's decision likely to come sometime next month (or by the PDUFA date of Aug. 30). Seattle Genetics has a shot, not only at its first FDA-approved drug, but also at bringing to market the first of a class of armed antibody drugs. What makes the drugs potentially powerful weapons against cancer is that they combine the binding properties of antibodies with the killer punch of toxins. While armed antibodies offer a potential way to precisely target cancer cells, the FDA showed last year with its decision not to approve a similar type of drug, Roche's T-DM1, the technological wonders aren't immune to additional regulatory hurdles. In its pursuit of approval of the drug, Seattle Genetics will be relying heavily on two single arm studies. Yet both studies have produced some stellar results, with its Hodgkin lymphoma trial showing the drug wiped out visible signs of disease in 34% of 102 patients, and with similar success in just over half of 58 patients with forms of anaplastic large cell lymphomas, to mention some of the key data. While Seattle Genetics clearly has the most at stake in brentuximab vedotin's success, a regulatory win would also be a victory for its partner for commericializing the drug outside of North America, Millennium: The Takeda Oncology Company. It could also bode well for others with a stake in the armed antibody game such as developer ImmunoGen ($IMGN), which provides the linking technology for Roche's T-DM1 and has its own pipeline of such drugs. - get the FDA staff review documents here
- read Bloomberg's report
- check out Xconomy's coverage Related Articles:
SGN-35 - 10 promising late-stage cancer drugs
Seattle Genetics ($SGEN) plots FDA app on promising PhIII cancer data Read more about: lymphoma, Seattle Genetics, brentuximab vedotin
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 | An Expert Briefing: Biotechnology 101- An Industry Overview for the Non-Scientist - Tuesday, July 26th, 1 pm ET / 10 am PT
Join us as we define biotechnology and briefly explore the various biotechnology sectors. We will also focus on the healthcare sector and explain how basic science and technology are used during the drug discovery process.
Topics include: DNA, Proteins, Recombinant DNA, Small and Large Molecule Drugs, and more Register today. |
2. Pfizer, J&J's Alzheimer's drug might get boost from FDA trial rules
There are no good drugs yet for treating Alzheimer's disease, which is notoriously complex and poses many challenges to developers. Yet with the nudging of industry and academics, the FDA has loosened some safety restrictions on trials for amyloid-lowering drugs against the disease, making it that much easier for companies like Pfizer, J&J and Eli Lilly to advance their experimental treatments, Reuters reports today. Since a dozen Alzheimer's patients had a brain-swelling condition in a 2008 study of Pfizer ($PFE) and J&J's ($JNJ) drug bapineuzumab, the FDA has made developers perform additional testing on patients who are in trials for such treatments and has restricted patients from participating if they have had more than two occurrences of certain small blood leaks in the brain, Reuters reports. With so many Alzheimer's patients experiencing such leaks, however, it's made it tough to get patients into trials and potentially slowed progress against the disease. So the FDA is letting some of the patients who have experienced the blo od leaks to participate in the trials. "We don't want to compromise safety, but we also want to make sure as many people as possible can participate in Alzheimer's clinical trials," said Maria Carrillo of the Alzheimer's Association, which advocated for easing the trial restrictions, told Reuters. Her group worked with industry and academics on a report on the topic that was published yesterday in the journal Alzheimer's and Dementia. There's a lot at stake in the development of Alzheimer's drugs for developers and patients. There are an estimated 5 million Americans and 26 million patients worldwide with the disease, and no drugs that address the root causes of the illness have been approved. While there's certainly skepticism about whether amyloid-lowering drugs are the answer, those experimental medicines a least offer a shot at progress. - read the Reuters piece
- here's an abstract of the report in Alzheimer's and Dementia Related Articles:
Researchers eager to see pivotal Alzheimer's data on bapineuzumab
Late-stage Alzheimer's drug targets two key culprits
J&J rattles analysts with long delay for Alzheimer's program Read more about: Alzheimer's, Johnson & Johnson, bapineuzumab, Eli Lilly
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3. BioSante's female sexual dysfunction drug draws partnering interest
BioSante CEO Stephen Simes says the developer is in talks with "many, many companies" about a potential partnership deal for its sexual dysfunction treatment LibiGel. The testosterone drug, which is applied directly to the skin, recently passed a Phase III safety trial. Since Viagra's approval in 2009, developers have advanced many possible treatments for the condition, but they have been unable to bring any to market. If BioSante is successful with this new therapy, it would represent the first approved treatment in a market worth up to $4 billion. "Nobody really wanted to touch BioSante when they had a three-, four-, five-year window ahead of them," Rodman & Renshaw analyst Elemer Piros tells Bloomberg. "The company is just being recognized, just starting to appear on people's radar screens." Recent safety data has drawn interest from potential partners, but the real test will come when BioSante gets Phase III data from two trials of the drug's effectiveness. The results are expected later this year. Analysts point to Pfizer (already experienced in the erectile dysfunction market), Endo Pharmaceuticals and Warner Chilcott as possible partners for LibiGel. BioSante could land up to $1 billion in a buyout early next year if the company's Phase III trials are successful. The developer hopes to file and NDA with the FDA next year and bring the drug to market by 2013. - read the Bloomberg article Related Articles:
BioSante's LibiGel passes saftey hurdle
BioSante gets good news on LibiGel
BioSante hits pay dirt with late-stage LibiGel data
BioSante, Cell Genesys merger will provide cash for Phase III Read more about: female sexual dysfunction, LibiGel, BioSante Pharmaceuticals
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4. Durect, Zogenix in deal for drug that could rival major J&J treatment
Durect has bounced back some from a regulatory setback last month with a brand new pact with developer Zogenix. The two companies struck a deal to develop a long-acting version of the antipsychotic drug risperidone, aiming to top the duration of Johnson & Johnson's blockbuster schizophrenia treatment Risperdal Consta. With the deal, Durect ($DRRX) gets $2.25 million upfront from Zogenix ($ZGNX) and the chance to reap $103 million in future payments. While these aren't huge sums, consider that that the companies' antipsychotic drug hasn't even entered clinical trials yet. Zogenix, which will take on all development and commercialization of the drug, aims to seek regulators' permission to begin a Phase I trial early next year, with the intent to develop the treatment for schizophrenia. For Durect, which is providing the technology for extending release of risperidone, the deal might help the firm recover a bit from a disappointment last month, when the FDA gave Pfizer ($PFE) and Pain Therapeutics ($PTIE) a disappointing complete response letter related to Remoxy, an extended-release version of oxycodone that uses Durect's tech. Zogenix plans to develop its version of risperidone called Relday that is given to patients once per month, using both Durect's tech and its own subcutaneous delivery system. Relday, if proven safe and effective, could offer more convenience to patients than twice-monthly injections of J&J's ($JNJ) Risperdal, which uses drug delivery tech from Alkermes ($ALKS). Still, it'll likely be years before Zogenix and Durect's contender poses any challenge to J&J's drug, which brought in sales of $1.5 billion in 2010, according to Durect. - here's Durect's release
- check out Reuters' coverage Related Articles:
Durect's pain drug fails to clear key hurdle in PhIIb
Zogenix aims for $78M with IPO Read more about: Biotech deals, Durect, schizophrenia, Zogenix
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5. Tarsa Therapeutics adds to $24.5M financing, advances osteoporosis drug
Drug development start-up Tarsa Therapeutics has rallied its investors for a financing that has totaled $24.5 million, with plans to use part of the cash infusion to move ahead with an application for approval of its experimental osteoporosis treatment. The young firm, which said in 2009 that it licensed its lead drug from Unigene Laboratories, aims to file an application for FDA approval of the oral recombinant salmon calcitonin for postmenapausal osteoporosis by late this year, after garnering positive Phase III data, according to the firm's release. It's also using some of its financing--which came from existing backers MVM Life Science Partners, Quaker BioVentures, Novo A/S and Unigene--to fund a Phase II study of the treatment to prevent osteoporosis in postmenapausal women with weakened bones. The firm has wrapped up enrollment of the 120-patient, placebo-controlled study. "We are encouraged by the continued positive developments in our oral calcitonin program," David Brand, Tarsa's president and CEO, said. "We are looking forward to presenting the full set of efficacy and safety data from the ORACAL trial this fall at the ASBMR meeting, the most important U.S. medical meeting in the osteoporosis field. We view the rapid completion of enrollment in our Phase II prevention study as another sign of the potential interest among physicians and patients for access to additional options for managing and preventing osteoporosis." Tarsa's executives have touted the fact that patients can swallow their version of calcitonin, which is now on the market only in intranasal and injectable forms. As some patients hate to get drug injections, which can pose challenges to getting them to take certain medications as prescribed, Tarsa's drug could be seen as a more convenient alternative. - here's Tarsa's release Related Article:
New biotech launched with $24M, PIII drug Read more about: Biotech Venture Capital, Tarsa Therapeutics
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Also Noted | This week's sponsor is Novella Clinical. |  | Your goal is to give people more opportunities to enjoy life's little moments. We’re proud to be a part of your mission, and promise to give you the individual attention you deserve, with therapeutic and in-country expertise to help reach your goal.
www.novellaclinical.com/bd |
SPOTLIGHT ON... Key R&D programs moving biotech stocks TheSteet's Adam Feuerstein takes at look today at some of the most actively traded biotech stocks today, highlighting a number of companies such as AVEO Pharmaceuticals ($AVEO), Targacept ($TRGT) and Vertex Pharmaceuticals ($VRTX). These developers are awaiting key clinical data that are expected to boost of sink some of the companies' stocks. If nothing else, it's a good primer for several important drug R&D programs in the biotech industry. Item  @FierceBiotech: Amgen widens cancer reach in $1B-plus Micromet deal. Story | Follow @FierceBiotech
> Bruce Booth of Atlas Venture and Highland Capital Partners' Bijan Salehizadeh have a new study that might dispel any myths about life sciences venture capitalist underperforming their tech peers. Blog > AMAG Pharmaceuticals ($AMAG) took a hit after the FDA slapped safety warnings on its lead drug Feraheme, but the company appears to be making a comeback. Article > Seeking Alpha has a piece that argues why drug developer Zalicus ($ZLCS) could be takeover bait for large companies like Pfizer ($PFE) and Amgen ($AMGN). Item > Proteros Biostructures says that it has renewed its pact with Rigel Pharmaceuticals to aid Rigel's drug discovery efforts with its structural biology services. Release Pharma News @FiercePharma: Novartis' desire for deals to return soon, CEO says. News | Follow @FiercePharma > PhRMA: U.S. drug discounts could cost 260K jobs. Report > Gilead first to jump into AIDS patent pool. Article > Novartis mulls IPO on China's planned int'l board. Item > EMA broadens safety review on Sanofi's Multaq. Story Biotech Research News > 'Super' stem cell keeps liver cancer going. News > NCI chief says no retreat from fundamental research. Story > Sunburn pain discovery could lead to better arthritis treatments. Article > Hutchinson takes lead on followup to 'Berlin Patient' HIV cure. Report > Metamark finds proteins that predict melanoma spread. News > New gonorrhea strain resistant to all available antibiotics. Story Manufacturing News > EU may add environmental regs to GMPs. Item > Lilly: Put law enforcement on the online fakes case. Story > Tamiflu concentration change aids dosing accuracy. Report > Chinese chemical inconsistency yields drug 'caveat emptor.' Story > Oncologist: U.S. may need drug czar to stem shortages. Article > Make generics look like brand drugs for safety. Item And Finally... Drug developer Intellikine says that it named former Celgene executive Gregory Berk as its chief medical officer. Release > An Expert Briefing: Biotechnology 101- An Industry Overview for the Non-Scientist Join us Tuesday, July 26th, 1 pm ET / 10 am PT as we define biotechnology and briefly explore the various biotechnology sectors. We will also focus on the healthcare sector and explain how basic science and technology are used during the drug discovery process. Topics include: DNA, Proteins, Recombinant DNA, Small and Large Molecule Drugs, and more. Register Today
| > BioImmersion: Biotech for the Non-Scientist - July 13-15, 2011 - Chicago, IL Three-day class delivering an in-depth understanding of both fundamental and advanced science and technology concepts. Focusing on the healthcare industry, participants learn about biologics- what they are, how they are discovered, how they are developed and how they are used as therapies. Learn More. > Partnerships in Clinical Trials Latin America - Aug 2011 - Sao Paolo, BR The world's leading clinical drug development and outsourcing event returns to Latin America for its 2nd Annual Partnerships in Clinical Trials Latin America meeting- bringing its unique formats, high-level strategic discussions, and unparalleled networking to Sao Paulo, Brazil. Visit www.PCTLA.com. > Rutgers Mini MBA: BioPharma Innovation Program > Skill-building and Summer Fun in Boston! Boston offers exciting summer options for visitors of all ages. You could see a movie in the local park, listen to a concert on City Hall Plaza, or learn to paint on the waterfront. So why not explore Boston in August and build your professional skills at the same time? > Online Pharmaceutical & Healthcare Marketing MBA for Executives Saint Joseph's University offers an expanded portfolio of globally accessible AACSB-accredited programs ideal for working professionals in the pharma, biotech, medical device, diagnostics and healthcare sectors. Apply now; our September Cohort begins 9/8. Visit sju.edu/epharma or call 800-SJU-EMBA. > Disruptive Innovations in Clinical Trials - September 15-16, 2011 - Philadelphia, PA Led by Pfizer and Novartis, this groundbreaking conference delivers only case studies that demonstrate either a disruptive or an innovative approach to advancing clinical trials. Mobile Clinical Trials, Virtual Trials, Open Source Clinical Development are just a few examples of case studies featured. Fierce readers receive 15% off with code FBEL. Register or learn more: click here > Partnership Opportunities in Drug Delivery - October 5-6, 2011 - Boston, MA Keynoted by Dr Robert Langer of MIT, this is a strategic level event for pharma and biotech BD&L executives to meet a wide range of drug delivery companies with the latest technologies. Fierce readers receive 15% off with code FBEL. Register or learn more: click here > BIO China 2011 - October 12-13 - Shanghai, China Organized by the Biotechnology Industry Organization (BIO) and Shanghai Zhangjiang Hi-Tech Park (Z-Park), BIO China will bring together executives from biotechnology, pharmaceutical companies and investment firms from North America, Europe and Asia to meet and explore business opportunities with China's emerging biotech sector. Registration Now Open.
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| > Regional BD Director We are considering candidates for a Regional Business Development (BD) Director to join our BD team! The ideal candidate should have specific experience calling on and selling into the R&D and clinical development/operations and study start up side of the industry, including but not limited to Phase I-IIIB as well as Phase IV post marketing surveillance, outcomes research and patient registry programs. Learn more. > Need a job? Need to hire? Visit FierceBiotech Jobs | |
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