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News Article | October 31, 2014
Site: www.xconomy.com

All types of scary news in the life sciences world in time for Halloween, from the highest levels of Big Pharma, where Sanofi’s board unceremoniously dumped CEO Chris Viehbacher, to biotech, where three local companies were put in the Wall Street penalty box. Details from the East Coast scene below: —Shares of Cambridge, MA-based Sarepta Therapeutics (NASDAQ: SRPT) fell sharply this week after the company revealed that it likely won’t file a new drug application with the FDA for its Duchenne Muscular Dystrophy drug, eteplirsen, until mid-2015 at the earliest. The FDA has made a series of new requirements of Sarepta, has questioned its method for tabulating its existing data, and asked for an independent assessment of it. The FDA even uncharacteristically published a response letter to explain its decision and dealings with Sarepta—a response to public pressures from patient advocacy groups. —Shares of Cambridge-based Aegerion Pharmaceuticals (NASDAQ: AEGR) also plummeted 30 percent after sales of its rare disease drug, lomitapide (Juxtapid), came in well short of expectations and the company significantly lowered its financial projections for 2014. It’s been a precipitous fall for Aegerion. The company traded at close to $90 per share in 2013, but has now lost more than two thirds of its value as lomitapide’s launch has disappointed. —Cambridge-based Akebia Therapeutics (NASDAQ: AKBA) was the third local biotech to get slammed by Wall Street. Akebia announced positive results for its oral anemia pill, AKB-6548—the drug met the primary endpoint of its Phase 2b study—but that release also revealed some potentially significant safety issues, including one patient death “possibly” related to treatment. —Cambridge-based Aileron Therapeutics added $33 million to its existing Series E round to help bring its stapled peptide drug targeting the tumor suppressor protein p53 to its first clinical trial. All of Aileron’s existing backers, including the venture arms of GlaxoSmithKline, Novartis, Eli Lilly, and Roche, participated in the funding. I spoke with CEO Joseph Yanchik about the financing, and the company’s plans for the coming study. —Watertown, MA-based Syros Pharmaceuticals raised $53 million in Series B cash from Polaris Partners, Aisling Capital, Redmile Group, Flagship Ventures, Arch Venture Partners, WuXi PharmaTech Corporate Venture Fund, and Alexandria Venture Investments. Syros CEO Nancy Simonian told Xconomy the cash should be enough to get the company’s first drug into clinical trials; its lead drug blocks a transcriptional kinase called CDK7. —Cambridge-based Affinivax emerged from stealth with a $4 million seed investment from the Bill & Melinda Gates Foundation. The company, spun out of the work of Richard Malley at Boston Children’s Hospital, is developing a platform for quickly and cheaply developing conjugate vaccines that provoke a broad immune response. I spoke with Malley and CEO Steven Brugger about that technology. —Shares of New York-based Bristol-Myers Squibb (NYSE: BMY) soared 8 percent after it posted encouraging data from a Phase 2 study of its PD-1 checkpoint inhibitor, nivolumab (Opdivo), in non-small cell lung cancer. Bristol reported 41 percent of the treated patients in its study were alive after one year, beating expectations. Separately, Bristol acquired an option to buy UK-based F-Star Alpha Ltd. and a cancer drug it’s developing for up to $475 million. —Cambridge-based Mersana Therapeutics said that Millennium Pharmaceuticals, the Boston subsidiary of Takeda, exercised an option to license an antibody-drug conjugate the two have been developing over the past seven months. Terms of the deal weren’t disclosed, however. —One week after Actavis (NYSE: ACT) nabbed an option to acquire a diabetic gastroparesis drug being developed by Rhythm Pharmaceuticals, the Boston company has pulled itself out of the IPO queue because of the deal. Rhythm filed in late August to go public.


News Article | June 13, 2012
Site: www.xconomy.com

Rhythm Drums Up $25M to Advance Diabetes and Obesity Drugs Boston-based Rhythm Pharmaceuticals is announcing today it has raised $25 million in a Series B financing round, bringing the total amount of capital hauled in by the two-year-old company to $65 million. Existing investors MPM Capital, New Enterprise Associates, and Third Rock Ventures participated in the funding, along with new investor Ipsen, the Paris-based drugmaker. Rhythm was founded on two compounds licensed from Ipsen—one to treat a digestion-related complication of diabetes, and another to treat severe obesity in people who have diabetes or are at risk of developing it. CEO Keith Gottesdiener says Ipsen’s decision to sign on as an investor “shows what looks to them like a lot of progress with these compounds.” Rhythm’s lead compound, RM-131, is in mid-stage trials to treat diabetic gastroparesis, a disorder marked by the delayed emptying of food from the stomach, which causes abdominal pain and bloating. Rhythm estimates that about one-third of the 24 million Americans with diabetes suffer from gastroparesis. There is one treatment—the generic drug metoclopramide—but it can cause a dangerous muscle disorder and therefore is not widely used. RM-131 is derived from ghrelin, a hormone in the stomach that promotes the movement of food through the digestive tract. On May 22, Rhythm announced that in an early trial, RM-131 reduced gastric emptying time by 66 percent. “That effect is the strongest seen with any drug that has effects on gastric mobility in diabetes,” Gottesdiener says. “That was the data that really encouraged us to go forward [with the trials] and convincing people to invest in the Series B.” A couple weeks later, Rhythm initiated mid-stage trials of RM-131. If all goes well, Gottesdiener says, those trials will … Next Page »


News Article | May 9, 2014
Site: www.xconomy.com

Pharma megadeals once again took center stage this week as more giant divisions were flipped, and the tension around a potential 12-figure, international buyout affecting thousands of workers across the globe escalated even higher. Those stories, and—oh yeah, biotech news—below. —Nothing is more closely watched in the life sciences world right now than the ongoing Pfizer/AstraZeneca saga, and for good reason. First, tensions are rising: Pfizer (NYSE: PFE) publicly boosted its bid to an astronomical $106 billion this week, and AstraZeneca (NYSE: AZN) responded with a presentation detailing why it’s worth way more than that. But also, there are a host of implications should that deal go down, starting with the thousands of workers that would likely lose their jobs, and then the massive portfolio review that will take place—impacting biotechs everywhere. With those issues in mind, I spoke with Francois Nader, the president and CEO of Bedminster, NJ-based NPS Pharmaceuticals (NASDAQ: NPSP) and a veteran of several pharma mergers, about the ins and outs of such deals from an employee perspective, an executive perspective, and that of the nervous biotech looking on. (Separately, NPS lowered its 2014 financial projections for sales of teduglutide (Gattex) to $100 million-$110 million from $110 million-$120 million, sending shares down more than 9 percent.) —Boston-based Rhythm Pharmaceuticals has been trying to replace a decades old, yet flawed treatment for diabetic gastroparesis—a debilitating, digestion-related complication suffered by people with diabetes. While there are still hurdles ahead, the company took a step towards that goal this week when its drug prospect, relamorelin, hit its goal in a Phase 2 clinical trial. Rhythm, a startup backed by the likes of MPM Capital, Third Rock Ventures, and others, plans to move the drug into its next study—likely a pivotal trial—by the end of the year. I spoke with Rhythm CEO Keith Gottesdiener and president Bart Henderson about the trial, and what comes next. —Tarrytown, NY-based Regeneron Pharmaceuticals (NASDAQ: REGN) is looking to gene therapy to produce a potential successor to its blockbuster drug aflibercept (Eylea). The company cut a deal this week with Menlo Park, CA-based startup Avalanche Biotechnologies to co-develop and commercialize gene therapy products for eye diseases, among them potentially the “wet” form of age-related macular degeneration—the disorder aflibercept treats. Avalanche—which just raised a $55 million Series B round in late April—got an unspecified cash payment up front and stands to add another $640 million down the road if the prospects to come out of the tie-up hit various milestones. All told, the deal covers eight therapeutic targets. Regeneron will get worldwide rights to all of the collaboration drugs that move forward, though Avalanche has an option to share the costs and profits of products aimed at two therapeutic targets of its choice. Regeneron also has a time-limited window to negotiate for rights to Avalanche’s wet AMD gene therapy prospect, AVA-101, after it finishes an ongoing Phase 2a study. Separately, Regeneron reported its first quarter earnings. Aflibercept generated $359 million in revenue, missing analysts’ consensus estimates by about $20 million. —Loxo Oncology was formed in New York last year by Aisling, subsequently picked up a preclinical cancer drug from Array BioPharma (NASDAQ: ARRY), and then raised $33 million to help develop it. This week, the biotech, now based in Stamford, CT, fattened up its wallet a bit more, announcing a $24 million Series B round led by New Enterprise Associates. Existing investors Aisling and OrbiMed Advisors also participated in the funding. Sara Nayeem, a principal at NEA and the former vice president of molecular discovery at Epizyme (NASDAQ: EPZM), has joined Loxo’s board. The company’s lead drug, known as LOXO-1, is now in Phase 1 testing. —The shuffling of Big Pharma divisions continued this week, as Whitehouse Station, NJ-based Merck (NYSE: MRK) sold its consumer care business—which includes brands like Dr. Scholl’s, Afrin, and Coppertone—to Bayer for about $14.2 billion. Merck also agreed to pay Bayer up to $2.1 billion as part of a separate deal to co-develop drugs for cardiovascular diseases. In addition, Merck appeared to leapfrog Bristol-Myers Squibb for the lead in the high-stakes cancer immunotherapy race: it filed an application with the FDA to approve MK-3475, its checkpoint inhibitor for cancer. Bristol-Myers has yet to do so with its rival drug, nivolumab. —Shares of Cambridge, MA-based Aegerion Pharmaceuticals (NASDAQ: AEGR) got slammed this week after sales of the company’s rare disease drug lomitapide (Juxtapid) came in well short of analysts’ expectations. Lomitapide generated $27 million in sales in the fourth quarter of 2013, compared with consensus estimates of around $33.6 million. Aegerion also cut its projected 2014 sales for the drug by about $10 million, to $180 million-$200 million for the year, blaming delays on orders for the drug in Brazil. Shares slid more than 22 percent on the news, continuing a precipitous fall for Aegerion during the first year of its drug’s launch. Shares were worth more than $88 apiece in July. They now trade at about $33 per share. —Natick, MA-based Boston Scientific (NYSE: BSX) made its latest acquisition this week, snapping up Cupertino, CA-based IoGyn. Boston Scientific already held a roughly 28 percent stake in the privately-held company, and is paying about $65 million to buy the rest of IoGyn and retire about $8 million worth of note debt it issued to the startup. IoGyn has developed and won FDA clearance of a minimally invasive system surgeons can use to remove intrauterine polyps and fibroids. —Watertown, MA-based Enanta Pharmaceuticals (NASDAQ: ENTA) landed another $20 million check from AbbVie (NYSE: ABBV) this week after the larger company filed an application with regulators in Europe to approve an all-oral regimen for hepatitis C including ABT-450, a drug the two companies co-developed. Enanta got a $20 million payout a couple weeks ago when AbbVie lodged an application with the FDA. —Retiring Biogen Idec (NASDAQ: BIIB) chairman William Young has joined the board of directors of Vertex Pharmaceuticals (NASDAQ: VRTX). Young announced plans to retire as Biogen’s chairman in February. He spent about four years in the role. Young is also the chairman of NanoString Technologies (NASDAQ: NSTG) and a venture partner at Clarus Ventures.


News Article | October 24, 2014
Site: www.xconomy.com

Deal flow is in full swing on the East Coast. At least three life sciences startups launched out of Boston and New York this week, with a few other firms filling up their bank accounts with either new funding rounds or partnership deals. Those stories and plenty more below: —Boston-based PureTech raised $55 million from a group of investors led by Invesco Perpetual, one of the largest investment fund managers in the U.K. I spoke with PureTech CEO Daphne Zohar about the raise, which should enable PureTech not only to launch a planned three to five startups in the coming year, but to pour a bunch of new cash—on top of that $55 million—into the existing ones in its portfolio. —Cambridge, MA-based Quartet Medicine came out of stealth this week with a $17 million Series A round from Atlas Venture, the venture arms of Pfizer and Novartis, and Partners Innovation Fund. The company aims to exploit new insights into the well-known tetrahydrobioprotein pathway to develop drugs for chronic pain conditions and bridge the gap between animals and the human trials that have doomed so many other pain drugs. —Cambridge-based Unum Therapeutics also launched this week, raising $12 million from Atlas, Fidelity Biosciences, and Sanofi-Genzyme BioVentures. Unum is joining the increasing crowd of companies touting ways to reprogram the immune system to seek out and attack tumors with chimeric antigen receptor T-cell therapy, or CAR-T. Unum’s twist on the concept is cancer treatments with a so-called “antibody-coupled T-cell receptor,” meaning it’s engineering T cells to find tumors with the help of antibodies. —Dublin drug giant Actavis (NYSE: ACT) paid $40 million up front for an option to acquire a drug Boston-based Rhythm Pharmaceuticals is developing to treat diabetic gastroparesis called relamorelin. Actavis can exercise an option to buy the drug, and Rhythm Health, the Rhythm subsidiary that owns it, after a Phase 2b trial that is expected to begin by early 2015. Separately, Rhythm also announced positive results from a Phase 2 trial of relamorelin in chronic constipation. —Waltham, MA-based Proteon Therapeutics (NASDAQ: PRTO) debuted on Nasdaq this week after raising $61 million in an IPO. Proteon had to sell more shares (6.1 million instead of 4.7 million) at a lower price ($10 instead of $12 to $14) than it initially planned to, however. —Cubist Pharmaceuticals (NASDAQ: CBST) said this week that CEO Mike Bonney will step down from his post on Dec. 31 and hand the reins to the company over to COO Robert Perez. Bonney has led Cubist for 12 years, and seen it rise from an antibiotics startup without a marketed product to a mid-cap biotech worth more than $5 billion. —Summit, NJ-based Celgene (NASDAQ: CELG) gave investors a glimpse into why it paid some $710 million up front and potentially $2.6 billion overall to an Irish drugmaker, Nogra Pharma, for the rights to an oral antisense drug for Crohn’s Disease. The company revealed data from a 166-patient Phase 2 study showing the drug, mongerson, helped induce remissions in a broad range of Crohn’s patients. Celgene will begin testing the drug in a Phase 3 trial by the end of the year. As Alex Lash reported, Celgene also cut a deal with Sutro Biopharma giving it an option to acquire the South San Francisco, CA-based company for an undisclosed sum. —In case you missed it, I posted a slideshow this week from our latest local biotech event, “Boston’s Life Science Disruptors,” which featured executives and investors from Zafgen (NASDAQ: ZFGN), Epizyme (NASDAQ: EPZM), and Sage Therapeutics (NASDAQ: SAGE). —Harris & Harris Group announced it’s formed a New York-based startup called Tara Biosystems. The Columbia University spinout is developing organ-on-a-chip technology to help boost the effectiveness of preclinical drug testing. Harris didn’t disclose the size of its investment, but managing director Misti Ushio is serving as the company’s founding CEO. The startup’s first project will be “heart-on-a-chip” tissue models. —New York-based Phreesia got a $30 million investment led by private equity firm LLR Partners, with participation from existing backers HLM Ventures and Ascension Ventures. Phreesia has developed a wireless tablet computer pad that helps patients check in for appointments at the doctor’s office and make payments electronically. —Shares of Cambridge-based Biogen Idec (NASDAQ: BIIB) dropped about 7 percent after the company disclosed that a patient taking its oral multiple sclerosis drug, dimethyl fumarate (Tecfidera) died from a rare brain infection called progressive multifocal leukoencephalopathy. Quarterly sales of the drug also came in slightly lower than consensus analyst estimates. Separately, Biogen hired neuroscientists Christopher Henderson and Richard Ransohoff to help its discovery and development efforts in neurodegenerative diseases. —The FDA this week extended its review of Bedminster, NJ-based NPS Pharmaceuticals’ (NASDAQ: NPSP) engineered version of human parathyroid hormone, known as Natpara, by three months and asked the company to submit a risk evaluation and mitigation strategy for the drug. An FDA advisory panel voted in favor of the drug, 8-5, in September, but the close vote left lingering questions about its commercial potential and what type of label the drug would get, if approved. The FDA will now decide whether to approve the drug by Jan. 24.


News Article | June 6, 2012
Site: www.xconomy.com

Updated 6/6/12, 4:20 am. See below. New England tech startups took the funding spotlight this week, for their offerings ranging from cloud archiving to online skill tests. —Newton, MA-based cloud archiving startup Sonian raised $13.6 million led by new investor OpenView Venture Partners. The deal also included  Sonian investors Prism VentureWorks and Summerhill Venture Partners, and will help Sonian explore ways its technology can back up different file types beyond e-mail. —Norwest Venture Partners led a $25 million Series D financing for Boston-based Gemvara, an e-commerce startup looking to make jewelry purchasing a more personal experience. Previous investors Highland Capital Partners, Canaan Partners, and Balderton Capital joined the deal, which brings Gemvara’s funding pot to a cool $50 million. —Cambridge Viscosity, a Medford, MA-based startup backed by the Massachusetts Technology Development Corporation, was acquired by Houston, TX-based PAC for an undisclosed sum.  PAC will integrate Cambridge Viscosity’s technology for measuring the viscosity of liquids into its inventory of analytical laboratory instruments, according to an announcement by MTDC. —Boston-based obesity and diabetes drug developer Rhythm Pharmaceuticals raised $9.5 million from four investors, toward a targeted $34 million equity round, an SEC filing shows. —Smarterer, the Boston-based startup offering online, crowdsourced skill tests, pulled in $1.75 million in Series A financing to bring its total funding to $3 million. The cash comes from previous investors True Ventures and Google Ventures, and about a dozen angels. —Lexington, MA-based Cartera Commerce nabbed another $12.2 million in equity financing to fund mobile development of its technology enabling banks and merchants to offer deals to consumers through their credit cards. Comvest led the funding, with return investors Flybridge Capital Partners, Dace Ventures, LBO Enterprises, and Venture Capital Fund of New England all participating. —Waltham, MA-based NetProspex, whose software enables users to find business prospects’ contact information, raised $7 million in Series B funding led by Edison Ventures. The money will be used to boost sales, partnerships, and product development. [Paragraph added to include new deal.] —And Nexage, the Waltham, MA-based mobile advertising exchange, announced it raised a Series B round to the tune of $10 million. The deal was led by SingTel Innov8, the corporate venture capital arm of the SingTel Group, and joined by existing investors Relay Ventures and GrandBanks Capital. [Paragraph added to include new deal.]

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