Today's Top Stories
1. New contenders will duke it out with Vertex for the hep C crown
2. Hot Ablynx antibody tech earns $69M discovery pact with Merck Serono
3. Biotech spin-out grabs $76M in venture cash for antibiotic work
4. Fledgling Rhythm recruits Merck vet to helm the Boston biotech
5. Bavarian Nordic sees positive results in small therapeutic cancer vax study Also Noted: Novella Clinical Resourcing
Spotlight On... Salix snags two new drugs in $300M Oceana buyout
Affymax settles J&J patent suit over anemia program; Mylan snags Pfizer delivery tech; skin cancer drug gets priority review; and much more... More Fierce Life Sciences News:
1. Class-action securities suit goes forward against Amgen
2. Mystery RNAi player taps Access Pharma for oral delivery tech
3. Collaboration supports early detection of pancreatic cancer
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> Biomarkers: Lab to Clinic. An eBook from FierceBiotech
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* General ad info: Click here | Today's Top News 1. New contenders will duke it out with Vertex for the hep C crown
The honeymoon is officially over for Vertex. A mere 6 months after gaining a landmark approval for the hepatitis C drug Incivek and quickly vaulting ahead of Merck's rival drug, grabbing a significant chunk of market share, Vertex finds itself grappling with a challenge posed by two biotechs with hot new treatments still in the clinic. And that sudden change of fortune is prompting the company to shift the spotlight to its own impressive pipeline of drug candidates. Over the first two days of the week Vertex shares ($VRTX) slid 17%, taking a significant chunk out of its market value. The two new darlings of analysts: Pharmasset ($VRUS) and Inhibitex ($INHX), each of which is hard at work on clinical development of new hepatitis C drugs that promise to potentially avoid the need for interferon injections. "We do now have to think about our portfolio longer term," Vertex CFO Ian Smith told analysts on Monday. The biotech, which is building a massive new headquarters complex in Boston, has a clear shot at gaining billions of dollars in Incivek sales. But the biotech champ is now talking up its market potential for the late-stage cystic fibrosis drug Kalydeco, a follow-up CF program for VX-809 and the next-gen hep C drug VX-222. And Smith was complimentary of Pharmasset, which has had recent successes in the clinic with PSI-7977. Robert W. Baird's Thomas Russo has emerged as one of the most skeptical analysts following the company. Vertex doesn't face any prospective competition on the hep C front for a couple of years, but there's no free ride for anyone in a drug development field as competitive as this one. - see the AP report
- check out the story from Xconomy Related Articles:
Vertex advancing all-oral Hep C pipeline amid big 3Q profits
Inhibitex skyrockets on promising oral Hep C drug program
Vertex seeks FDA approval stamp for breakthrough CF drug Read more about: Hepatitis C, vertex, Pharmasset, Inhibitex
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2. Hot Ablynx antibody tech earns $69M discovery pact with Merck Serono
Just days after a rapidly downsizing Pfizer offloaded a partnership with Belgium's Ablynx on its hot nanobody technology, Merck Serono has stepped up to the plate with a fresh $28 million upfront payment to expand their ambitious antibody development partnership. This third pact covers the co-development of two new therapies for osteoarthritis, with $41 million in milestones up for grabs if Merck Serono opts to accept the preclinical packages that Ablynx offers. "We are impressed by the speed with which Ablynx has progressed in our ongoing programmes and we believe they could become a valuable source of new drug candidates for Merck Serono," said Dr. Bernhard Kirschbaum, head of global discovery and early development at Merck Serono. "We believe that the specific features of the nanobodies have the potential to address key challenges in the treatment of osteoarthritis." Ablynx shares ($ABLX) were up about 7% on the news this morning. Antibodies are hot, a theme that Deloitte Recap hit on yesterday as it analyzed the deal terms in the field. Deloitte Recap analyst Jennifer Doyle in particular noted that the kind of domain antibodies that Ablynx works on are particularly appealing to Big Pharma partners today. Pfizer ($PFE) handed back a portfolio of nanobody programs for rheumatoid arthritis--including the mid-stage drug ATN-103 and PF-05230905, which is in early-stage development--obtained in the Wyeth buyout. Ablynx and Merck Serono originally partnered three years ago, adding a second program in 2010. - here's the press release Related Article:
Pfizer dumps rights to RA drugs from biotech Ablynx Read more about: Pfizer, antibodies, Merck Serono, Ablynx
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3. Biotech spin-out grabs $76M in venture cash for antibiotic work
Just a few months after Axcan swept in to buy up the San Diego-based Mpex and its lead antibiotic program, the former CEO of the developer has successfully spun out the rest of the pipeline into a new company dubbed Rempex and snagged venture commitments now totaling a whopping $76 million. A new B round announced today adds commitments for up to $67.5 million from SV Life Sciences, OrbiMed Advisors and Adams Street Partners. Rempex, which launched last June, says it is prepping an NDA for a new treatment for resistant gram-negative infections in the second half of 2012. An IND on a second product is due early next year. "This financing gives us the resources to rapidly advance our development programs towards commercialization at a time when the need for new treatments for resistant gram-negative infections has become critical," said Rempex CEO Daniel Burgess. Axcan, which later changed its name to Aptalis after merging with Eurand, bought out Mpex in order to gain control of Aeroquin, then a Phase III treatment for pulmonary infections in patients with cystic fibrosis. - here's the press release Related Articles:
Axcan to buy Eurand for $583 million
Axcan accepts $1.3 billion buyout offer Read more about: antibiotic, Axcan Pharma, Rempex
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4. Fledgling Rhythm recruits Merck vet to helm the Boston biotech
 Rhythm, a venture-backed biotech startup based in Boston, has hired a Merck vet to head the company as it prepares to push two development programs past early-stage development and into the mid-stage arena. Dr. Keith Gottesdiener (pictured) has been recruited to take the helm of the fledgling drug developer after completing a stint as Merck's late-stage therapeutic group leader, which gave him authority over the pharma giant's pivotal trials. He had previously been Merck's chief of early-stage clinical development.
Co-founders Bart Henderson and Liz Stoner set up the company, snagging a $21 million original A round from MPM Capital and New Enterprise Associates in early 2010. Stoner is a managing director at MPM, where Henderson had landed a position as entrepreneur-in-residence. The initial round was later expanded to $40 million when Third Rock Ventures stepped in as a backer, drawn by its work on GI metabolic disorder, obesity and diabetes. Lou Tartaglia, a partner at Third Rock, has been filling in as chief scientific officer, and Henderson says that Rhythm plans to name a full-timer for that key slot in just a few weeks. The new CEO will be entirely focused on RM-131 for the treatment of diabetic gastroparesis--a problem with gastric emptying characterized by some painful side effects--and RM-493 for obesity and diabetes. The RM-493 treatment cleared a primate study with an average weight loss of 13% and a clean safety bill, says Henderson. RM-493 is starting a Phase I study with a mid-stage trial expected to launch next year. RM-131 has completed Phase I and is slated to transition into Phase II next year as well. "We spun both programs out of (France's) Ipsen," says Henderson, the president of Rhythm. "They had done the discovery work and we invested in both programs because the depth of the preclinical data was so broad and strong and really supported our view that peptides have the advantage for targeting metabolic targets." Henderson notes that Rhythm is still very much a virtual company, but it's been steadily piecing together an experienced team of industry players to run the company. If all goes according to plan, the biotech will start seeking out partnership deals around the end of Phase II, a classic inflection point for most drug developers. - here's the Rhythm release Related Articles:
Third Rock pushes Rhythm venture round to $40M
Rhythm Pharma raises $21M for metabolic diseases Read more about: Rhythm Pharma, Keith Gottesdiener
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5. Bavarian Nordic sees positive results in small therapeutic cancer vax study
Just weeks after gaining rights to an off-the-shelf therapeutic cancer vaccine involved in a collaboration with the NCI and NIH, Bavarian Nordic says that CV-301 produced some positive results in a small but potentially significant study involving patients with advanced breast and ovarian cancers. Relying on NCI funding, investigators recruited 26 patients and gave them monthly injections of the cancer vaccine. The median overall survival rate for the 12 breast cancer patients hit 13.7 months, with median time to progression hitting 2.5 months. The researchers added that one breast cancer patient demonstrated a complete response and remained in the study for more than 37 months. The 14 ovarian cancer patients experienced a median OS rate of 15 months with median TTP at 2 months. Treatment with CV-301 was reported to be well tolerated, with mild injection-site reactions representing the most common side effect. Reiner Laus, president of the cancer vaccine division, noted that the study indicates that "overall survival, rather than time to progression or tumor shrinkage, may be a more relevant clinical endpoint in evaluating the effects of immunotherapies. The sustained benefit seen in some patients receiving CV-301 provides additional insight into the potential of this therapeutic vaccine and we look forward to results from an ongoing randomized Phase II study of CV-301 in patients with metastatic breast cancer." - here's the press release Related Article:
Bavarian Nordic spotlights hopes for big cancer vax pact Read more about: breast cancer, ovarian cancer, Bavarian Nordic, CV-301
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Also Noted | This week's sponsor is Novella Clinical Resourcing. |  | Your goal is to enable people to enjoy life's special moments, and we're proud to join you in your pursuit. Our promise is to match your clinical trial specifics with resourcing insight and strategy that moves your program's potential forward. See how at novelladreamteam.com |
SPOTLIGHT ON... Salix snags two new drugs in $300M Oceana buyout Salix is snapping up Oceana Therapeutics for $300 million. Oceana has a pair of drugs on the market: Deflux, which is used to treat vesicoureteral reflux, a bladder problem known to trigger severe kidney infections and kidney damage in kids, and Solesta, a "tissue bulking agent" which can be used to treat incontinence. Story  @FierceBiotech: Alkermes keeps drug-delivery ties intact in Lilly-Amylin breakup. Article | Follow @FierceBiotech
@JohnCFierce: Startup Rhythm (Boston) gets Merck development vet Keith M. Gottesdiener as new CEO. Release | Follow @JohnCFierce @RyanMFierce: Mylan is buying Pfizer's respiratory drug delivery tech. Release focus is on COPD. | Follow @RyanMFierce @MaureenFierce: Chuck Norris (yes, Chuck Norris) is the newest anti-vaccine activist. Celebrities + science=fun! More | Follow @MaureenFierce > Could kidney damage biomarkers speed drug development? Article > Long-term survival in advanced head and neck squamous cell carcinoma (HNSCC) is poor, particularly in China, and the biomarker cyclin D1 (CCND1) is linked with resistance to chemotherapy treatment and worse outcomes. A team of Chinese researchers is working on a CCND1-based assay that could be used to predict which patients would benefit the most from neoadjuvant cisplatin-based chemotherapy before surgery and radiation therapy. Article > Affymax has agreed to pay up to $13 million to settle patent litigation with J&J over its experimental anemia drug peginesatide. Story > Look out, GlaxoSmithKline ($GSK). Mylan ($MYL) has snapped up some drug delivery technology from Pfizer ($PFE), aiming to knock off GSK's blockbuster respiratory drugs Advair Diskus and Seretide Diskus. The drugs, which are used to treat asthma and chronic obstructive pulmonary disease, are big sellers for the U.K. drugmaker. Story > Genentech's skin cancer drug vismodegib has landed priority review status at the FDA, helping to burnish its regulatory prospects and confirm Roche's market-leading position in clinical development. Report > Almac says it plans to offer some 500 new jobs as it ramps up its development plans. Story > A small Johns Hopkins biotech spinout is well on its way to meeting its goal of raising a million dollars to back its research on new treatments for eye diseases. Story Pharma News @FiercePharma: Shanghai Pharma's ex-CEO gets suspended death sentence in bribery/graft case. If he behaves, he'll get life in prison News | Follow @FiercePharma > Class-action securities suit goes forward against. Report > Amgen Judge orders GSK to mediation in Avandia suits. News > Pharmacies accuse Pfizer, Ranbaxy of secret Lipitor deal. Report > Mylan snags Pfizer's Advair copy, inhaler technology. Article > CBO: Pay-to-delay ban could save $4.8B. Report Medical Device News > Pivot secures $32M in Series C. Piece > FDA clears Cordis' Empira catheters. Item Drug Delivery News > Sunovion's inhaled steroid for allergies looks good in Ph3 amid FDA review. More > Alkermes keeps drug-delivery ties intact in Lilly-Amylin breakup. Story > Bioject axes 38% of staff as needle-free biz faces revenue, FDA hurdles. Article > Neuroderm reportedly sees promising data for Parkinson's drug patch. Report And Finally... Scientists at The University of Nottingham are spearheading a project to develop an in vivo biological cell-equivalent of a computer operating system. Report > Getting the most out of First-in-Human and Early Clinical Trials - Nov 15, 2pm ET / 11am PT In a follow-up to our webinar last month on first-in-human drug studies, FierceBiotech editor, John Carroll is hosting a second discussion on the increasing complexity of first-in-human/early clinical pharmacology studies. Three trial experts will present real-life case studies of trials that went well beyond the standard safety and PK assessments in typical FIH studies is recommended. Register now.
| > BioImmersion Course - Nov 9-11 - Chicago, IL Understand the key science, applications and terminology in your industry. This three-day course delivers an in-depth understanding of both fundamental and advanced biotechnology concepts used in both biotech and pharma companies. View Agenda. Register today! > Life Science in the Cloud - Nov 16, 2011 - Cambridge, MA Join Accelerys, Appistry, BiogenIdec, Linguamatics, Novartis and Pubget to network and explore cloud computing from those that have been there. http://lifesciencecloud.eventbrite.com/ #lifescicloud11 > Just Released: New Trends in Preventive and Therapeutic Vaccine This new Insight Pharma Report analyzes current R&D activities and commercial prospects for vaccines. Sectors covered include bacterial infections; viral infections including hepatitis, HIV, influenza, and others; autoimmune diseases, cancer, and many more. For more info, www.insightpharmareports.com > New Paradigms to Fund & Move Biotech - January 11-12, 2012 - San Francisco, CA New Paradigms is guided by key individuals from biotech, pharma and the investment community to advance R&D through alternative sources of funding, non-traditional partnering strategies and innovative approaches to drug approval for the successful commercialization of new therapies. The conference is backed by an exceptionally distinguished speaking faculty with diverse experience and expertise. Co-located at the same time as the JP Morgan Healthcare event, on-site networking partnering services available to registered attendees. Register today! 20% off registration fee for Fierce Readers with code FBNP > Pharmacovigilance and Risk Management Strategies 2012 - January 22-25, 2012 - Arlington, Virginia Get New Insights into the Current Issues and Associated Challenges Impacting Drug Safety. Join top pharmaceutical, biotech, and regulatory representatives to discuss the new and updated legislation in various ICH regions, important new harmonization initiatives, life cycle management, the impact of social media, biosimilars, and the use of other data sources and observational research, and much more! Register today and SAVE $200! > Partnerships in Clinical Trials 2012 - March 4-7 - Orlando, FL Partnerships is the largest clinical trial operations, development and outsourcing meeting in the world with over 1500+ attendees and 200 exhibitors. This leading event is a unique senior leadership meeting focused on overcoming challenges clinical trial executives face. Visit www.cliicaltrialpartnerships.com.
| > Fierce Special Report: Cloud Primer for Life Sciences Execs Our newest report highlights the growth of cloud service IT applications while providing examples of cost savings and efficiency gains that suggest the cloud is gaining traction in the life sciences industry. Download for free today! > Biomarkers: Lab to Clinic. An eBook from FierceBiotech Don't miss this in-depth look at biomarkers. What role do they play in clinical trials? How do they factor into the diagnosis of diseases such as Alzheimer's? What role does the FDA play in creating guidelines for biomarkers? Get the answers to these questions and more when you download this free eBook.
| > Manager, Strategic Forecasting & Analytics – NJ – Celgene Corporation Celgene Corporation is a global biopharmaceutical company that is helping to turn incurable cancers into chronic, manageable conditions. An ideal candidate for this position will have a BS/BA and 5 to 7 years financial and/or forecasting experience (pharmaceutical/biotechnology industry experience required). This position will provide ongoing forecasting and long-range analytical support for the Americas Hematology/Oncology business and will participate on cross-functional teams....Learn more. > Hematology Oncology Consultant, Hematology – Louisiana, LA – Celgene Corporation Celgene Corporation is a global biopharmaceutical company that is helping to turn incurable cancers into chronic, manageable conditions. An ideal candidate for this position will have a Bachelor's degree in Business or Science; minimum of 5 years' sales experience in the pharmaceutical/biotechnology industry with two years Oncology experience preferred. This position will be responsible for achieving all territory sales goals through the promotion, sale, and support of company products or services in his/her geographic territory. The territory includes Baton Rouge, Louisiana to Shreveport and Monroe, Louisiana (must live in territory)...Learn more. > Need a job? Need to hire? Visit FierceBiotech Jobs | |
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