Today's Top News Friday, March 11, 2016 | By Damian Garde
| | Five Prime CEO Lewis Williams |
GlaxoSmithKline ($GSK) is cutting ties with Five Prime Therapeutics' ($FPRX) in-development cancer therapy, backing out in the middle of a mesothelioma trial. GSK gave Five Prime a 180-day notice that it's nixing its license to the company's FP-1039, which is designed to block the spread of cancer by interrupting protein signaling. The decision follows GSK's January move to stop developing FP-1039 in squamous non-small cell lung cancer due to the rise of immuno-oncology therapies from Merck ($MRK), Bristol-Myers Squibb ($BMY) and others, citing a "change in treatment paradigms." Now GSK is set to abandon a drug it inherited through its $3 billion acquisition of Human Genome Sciences in 2012, leaving Five Prime to go it alone in an ongoing Phase Ib study testing FP-1039 against mesothelioma. Five Prime said it plans to work with GSK to complete enrollment in the study, adding that it "continues to be encouraged" by the drug's potential in mesothelioma. While GSK is backing away from Five Prime's oncology pipeline, the two companies remain partnered up in respiratory R&D. In 2014, GSK re-upped with Five Prime on a discovery-focused partnership to develop new therapies for refractory asthma and COPD. The expanded deal follows a 2012 tie-up between the two companies, and Five Prime is in line for up to $193.9 million per project. Five Prime is still riding high on an October agreement with Bristol-Myers through which it pocketed $350 million up front and signed up to reap as much as $1.4 billion more in exchange for the rights to an immunology program. Bristol-Myers bought into Five Prime's antibody's for colony stimulating factor 1 receptor, including lead asset FPA008, in hopes of pairing the immune-regulating treatments with its own cancer therapies. Five Prime's shares are up about 82% since the deal. - read the statement Related Articles:
GlaxoSmithKline and Five Prime ditch lung cancer ambitions as rivals pile in
Bristol-Myers inks a blockbuster $1.74B deal for an Opdivo combo drug
GlaxoSmithKline cozies up to Five Prime for respiratory R&D
Thursday, March 10, 2016 | By John Carroll
| | A breakdown on responses from APOE4 carriers. Click to enlarge. |
Like just about every other Alzheimer's drug that's been through Phase III studies in the past decade, tramiprosate failed to demonstrate a significant impact on patient's lives. But now that Alzheon is gearing up for a late-stage program of its own, the Framingham, MA-based biotech is breaking down the data to show why they think a tweaked version of the therapy can work. And they're taking a page from rivals' play books in making the case that new and better tech can correctly identify a patient group who can be helped, possibly paving the way to a positive outcome. Alzheon CEO Martin Tolar--who had helmed George Church's Knome, an early attempt at consumer genomics that floundered and was bought out last fall--and his team have a revised, prodrug version of tramiprosate, now ALZ-801, that they believe will be much more tolerable, suitable for daily dosing. And like Eli Lilly ($LLY), Axovant ($AXON) and vTv ($VTVT), their team wants you to see why failed Phase III studies can justify a jump straight back into the clinic with a new and better pivotal clinical strategy. The key to its case--laid out today at an Alzheimer's conference in Athens--lies in a genotype subgroup of patients identified as APOE4/4 homozygous. These patients are genetically at risk for the disease and are more likely to have excess deposits of amyloid in the brain, the toxic clusters that many believe--but have yet to absolutely confirm--spurs the memory destroying ailment that afflicts tens of millions of people. Their drug also targets amyloid deposits. "The more amyloid you have in the patients, the more efficacy we see," says Tolar. And because the study recruited large numbers of patients who didn't have the right genetic profile, the data were necessarily corrupted by subjects who couldn't benefit from the drug. Like others, Tolar likes to point to the leaders in the field for support. Biogen's ($BIIB) aducanumab, now in its own Phase III after posting mixed data, helped establish amyloid as a legitimate target, even after Eli Lilly and Johnson & Johnson ($JNJ) flopped on their first tries. But to be sure, even tracking his chosen drug subgroup's performance against others, all the patients' performance declined, reflecting another common pattern of the most advanced drugs in the clinic. No one here is offering a cure, just a stay of execution. Breaking out the data on that APOE4 subgroup, says Tolar, you can see a clinically meaningful benefit on cognition and/or function on top of standard of care through 78 weeks of treatment. "Data from the APOE4/4 homozygous subgroup in the North American study suggested a dose-dependent clinical benefit at the high dose of tramiprosate compared to placebo (N=147, nominal p-value: 0.04)," the company adds in a statement. "APOE4 heterozygous subjects showed lower magnitude of effect with a significant clinical benefit on function and positive trends on cognition. Patients who were APOE4 non-carriers did not show benefit from tramiprosate at either dose." Alzheon raised $10 million in a round led by Ally Bridge last summer to get its ducks lined up in a row for their upcoming study, which Tolar says should last "several years." And while he's not telling me any of the details about his business plan--like the length and cost of the study--he's likely far more forthcoming to the investors he's talking to. At the end of the day, though, trying to convince investors that a failed Phase III drug is gold can be a very, very hard slog. But it's doable. Axovant executed a record IPO worth billions, on an asset from GlaxoSmithKline ($GSK) that cost a pittance, but saw that shrivel in the face of a bear market. Even vTv raised more than $100 million on an IPO. And analysts remain fascinated by the prospects of Lilly's solanezumab, even if they generally refuse to build Alzheimer's money into their revenue models. But with the potential blockbuster windfall waiting for anyone who can be the first to move the dial even slightly on Alzheimer's, Tolar and his band believe they can compete. And if they can raise the funds, they will. - here's the release Related Articles:
Alzheimer's startup Alzheon bags $10M and beats a path to Phase III
Biogen's Alzheimer's drug impresses in early study with Phase III on the way
Alzheimer's R&D suffers as trial failure rate hits an 'astounding' 99.6%
Alzheimer's team tackles a daunting R&D field with a new game plan Friday, March 11, 2016 | By Damian Garde
Sanofi ($SNY) and Regeneron ($REGN), awaiting FDA approval for a potential blockbuster rheumatoid arthritis treatment, burnished the drug's profile with Phase III data showing it beat AbbVie's ($ABBV) top-selling Humira head to head. The treatment, sarilumab, is an antibody targeting the inflammation-related protein interleukin-6 to treat autoimmune disease. In a late-stage trial enrolling 369 patients, the therapy beat out Humira in clearing up rheumatoid arthritis symptoms after 24 weeks by a statistically significant margin, at the same time meeting secondary goals of improving disease scores and physical function, Sanofi and Regeneron said. On the safety side, the two treatments came through with similar rates of the most common side effects, according to the companies, but sarilumab led to more instances of neutropenia, which affected 14% of patients versus just 1% of those taking Humira. The partners have already submitted sarilumab for FDA approval, and the agency has promised to hand down a decision by Oct. 30. Regulators won't consider the antibody's head-to-head victory over Humira in their review, but the positive data will likely help Sanofi and Regeneron make their case to payers and physicians if and when sarilumab is approved. The treatment has long been pegged as a blockbuster in waiting, with 2020 sales predicted to hit $1.8 billion, according to analyst estimates compiled by EvaluatePharma. Sarilumab is positioned to become the second approved product to come out of from Sanofi's wide-ranging partnership with Regeneron, following last year's launch of Praluent, an antibody designed to clear out bad cholesterol by blocking a protein called PCSK9. Analysts expect that treatment to eventually bring in as much as $3 billion as it competes with a similar injection from Amgen ($AMGN), also approved in 2015. Sarilumab has already demonstrated its efficacy in 7 Phase III trials in more than 2,500 subjects, beating out placebo in a variety of RA disease states and making a difference for patients who can't tolerate Humira and its rival Enbrel, made by Amgen. - read the statement Related Articles:
Sanofi and Regeneron line up for FDA approval with an arthritis treatment
Regeneron plots a $150M R&D expansion, adding 300 jobs at its New York hub
Struggling Sanofi paying $1.8B to partner with Regeneron on immuno-oncology Friday, March 11, 2016 | By Damian Garde
| | Corvus CEO Richard Miller |
Corvus Pharmaceuticals, founded by some of the brains behind Pharmacyclics, set terms for an IPO that could raise as much as $80 million, hoping to brave choppy waters for biotech on Wall Street and fund its pipeline of cancer drugs that harness the immune system. The Burlingame, CA, company is looking to price 4.7 million shares at between $15 and $17 each, setting aside another 705,000 shares for its underwriters to cover overallotments. The plan is to trade on the Nasdaq under the symbol "CRVS," going public after fewer than 18 months of existence. With the funds, Corvus plans to push forward with four cancer therapies in early development. The most advanced, CPI-444, targets one of the body's G protein-coupled receptors to help the immune system home in on cancers, and Corvus began a Phase I trial in patients with solid tumors in January. Behind that is a preclinical antibody targeting the cancer-related antigen CD73, which Corvus expects to get into clinical trials next year. The biotech is also in the lead-optimization stage with two other cancer programs, aiming to select a development candidate for each this year. Corvus got off the ground in 2014, co-founded by former Pharmacyclics executives Richard Miller and Joseph Buggy, plus OrbiMed Partner Peter Thompson. The firm closed a $33.3 million Series A round the following year, raising $74.8 million more in September from a syndicate that includes OrbiMed, Novo A/S, Roche ($RHHBY) Venture Fund and Fidelity. The company is attempting to go public in an uncertain climate for biotech IPOs. The year began with a drought as industry indexes slumped and investors seemed to lose interest in drug developers. But successful February offerings from Editas Medicine ($EDIT) and BeiGene ($BGNE) cracked the IPO window back open for biotech, and a handful of companies have managed to make their way to Wall Street in the weeks since. - read the filing Related Articles:
Syndax braves a market tempest in second IPO try, scores a $53M raise
Biotechs launch an IPO blitz as Nasdaq stumbles out of the gate
Execs behind Imbruvica raise $75M for a new cancer project Friday, March 11, 2016 | By Damian Garde
| | TrialReach's Pablo Graiver |
A former executive at travel booking site Kayak.com has launched a matchmaking service for clinical trials, hoping to expand the platform to allow patients to find studies as easily as vacationers book flights. Dubbed TrialReach, the London-based startup is hoping to create a global database of clinical trials actively recruiting patients, allowing users to search for studies sponsored by pharma and academia. For now, the site only indexes U.S. trials focused on diabetes, but TrialReach told Bloomberg it plans to expand the scope to include 14 more diseases by the end of the year. The site works like this: Patients answer questions about their vitals, symptoms and prior treatments, and TrialReach generates a list of nearby studies. Each study listing describes its goals and duration in jargon-free language, and TrialReach allows users to connect with investigators straight from the site. The company has already recruited Novartis ($NVS), Pfizer ($PFE) and Eli Lilly ($LLY) to back its technology and list their studies on the site, and CRO giant Parexel International ($PRXL) has come on board as well. The company told Bloomberg it has agreements with most of the world's 25 biggest drugmakers and CROs, and it's working to expand its presence in the industry. Ex-Kayak Vice President Pablo Graiver got TrialReach up and running in 2009 with the help of friend and cardiologist Jessica Mann. The company has since raised about $20 million in venture capital, poaching executives from Shazam, Lilly and Investec along the way. - read the Bloomberg story
- check out the site Related Articles:
Lilly, Novartis and Pfizer give trial-patient matching tech to TrialReach
TrialReach raises $13.5M for clinical trial-patient matching service
Advocacy groups launch new services to match patients and trials Friday, March 11, 2016
Welcome to this week's Chutes and Ladders, our roundup of hirings and retirings throughout the industry. Please send the good word--or the bad--from your shop to Eric Sagonowsky (email) or Amirah Al Idrus (email | Twitter), and we will feature it here at the end of each week. | CEO Jay Flatley to step aside after 17 years of growth at Illumina | | | | Illumina
CEO Jay Flatley announced he's stepping down. |
Illumina ($ILMN) CEO Jay Flatley has announced he's stepping down after 17 years at the post, handing the reins to Francis deSouza effective July 5. Flatley will head to the executive chairman's office after a tenure that saw the San Diego company grow yearly revenues from $500,000 to $2.2 billion last year. Flatley, who managed the company's expansion from 30 employees in 1999 to more than 4,800 in 2015, said "the time is right" for deSouza, currently Illumina's president, to shift into the CEO role. DeSouza joined in 2013 and has since worked with the board and the company's top management, including Flatley, to spur product development and marketing. "Today, having witnessed the impact our technology has on patients' lives, and having experienced the passion and dedication of our employees, I could not be more honored, or more confident in our future," deSouza said in a statement. Story | Sanofi pulls in former Novartis exec Ameet Nathwani for CMO job | | | | Sanofi
Dr. Ameet Nathwani was named chief medical officer. |
Sanofi ($SNY) poached former Novartis ($NVS) exec Dr. Ameet Nathwani for its chief medical officer position this week, replacing Dr. Paul Chew, who is retiring later this year. Nathwani, who was also named EVP, brings to Sanofi more than 20 years of experience in the pharma industry, previously holding down various leadership roles at Novartis, Glaxo, SmithKline Beecham and GlaxoSmithKline ($GSK) in Europe and the U.S. At Sanofi, he'll work with the Global R&D and Global Business units and be responsible for patient safety and medical quality assurance, working to provide "the highest standard of transparency and compliance in Sanofi's interactions with healthcare providers, patients and medical organizations," Sanofi's release said. "We are very happy to count on Ameet's strong experience in both development and medical fields," Sanofi CEO Olivier Brandicourt added. "I would also like to take this opportunity to thank Paul Chew for his many valuable contributions to Sanofi. During his long-standing career, Paul has been a highly valued and key Sanofi leader who has demonstrated strong medical leadership." Release | Hoping to rebound, KaloBios hires Cameron Durrant as CEO | | | | KaloBios
Cameron Durrant was named CEO. |
Seeking to move past recent struggles, this week KaloBios named Cameron Durrant its next CEO. He'll be tasked with guiding the company through its next stage after a rocky recent history that includes an announcement that it was closing, Martin Shkreli's short-lived CEO stint, a share price roller-coaster ride and an eventual Nasdaq delisting. The company filed for bankruptcy late last year and will now seek to regroup. Durrant brings to the biotech industry experience from leadership roles at ECR Pharmaceuticals, PediatRx, PediaMed Pharmaceuticals, Taran Pharma, Johnson & Johnson ($JNJ), Pharmacia, GlaxoSmithKline and Merck ($MRK). Filing Baxalta laid off 120 employees in California. Story Reeling from an FDA rejection, Telesta shed 15% of its staff. Story |
| Biotech > Synergy Pharma ($SGYP) appointed Marino Garcia as chief strategy officer. Release > XTL Biopharma ($XTLB) named Dr. Daphna Paran as medical director. Release > Rigel ($RIGL) appointed Dr. Anne-Marie Duliege as chief medical officer. Release > Therabron Therapeutics hired Dr. Alan Cohen as senior vice president and chief medical officer and Linda Chang as senior vice president and chief financial officer. Release > Sutro Biopharma appointed Dr. Arturo Molina as chief medical officer and Mark Lupher as vice president of translational pharmacology and preclinical development. Release > Medgenics hired Rick Couch as vice president of chemistry, manufacturing and controls. Release > CohBar appointed Simon Allen as CEO. Release > Kuros Biosciences appointed Dr. Virginia Jamieson as chief medical officer. Release > Arrogene named Jack Kavanaugh as its chairman and executive chairman. Release > CorMatrix hired Andrew Green as its president and COO. Release > Peter Mitchell joined Cocoon Biotech as its chief scientific officer. Release > Scholar Rock appointed Dr. Yung Chyung as its chief medical officer. Release > Merck named Sanat Chattopadhyay the president of its manufacturing division, succeeding Willie Deese. Release > Arbutus Biopharma appointed Elizabeth Howard as its executive vice president and general counsel. Release > Immunome appointed Michael Morin as its president and chief scientific officer. Release Pharma > Dr. Richard Ghalie has joined MEI Pharma ($MEIP) as senior vice president of clinical operations. More Med tech > Jonathan Rennert, president of Zoll Medical's resuscitation business, will become CEO, as current CEO Richard Packer moves to a new role leading Zoll parent Asahi Kasei's Health Care Business Unit. A. Ernest Whiton, currently senior vice president of international operations, will replace Rennert as president of resuscitation business. Release > Neural Analytics named Dr. Neil Martin as chief medical officer. Release |
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