Friday, September 14, 2018
Mallinckrodt initiated at Berenberg
Mallinckrodt initiated with a Sell at Berenberg. Berenberg analyst Patrick Trucchio initiated Mallinckrodt with a Sell and $25 price target due to opioid exposure. Trucchio said the company faces over 100 opioid-related lawsuits which could end with a large settlement and limit or prevent the sale of its opioid generics business. Further, he believes Acthar could be pressured following the adverse analyses published by JAMA and from new and emerging MS treatments with less relapses.
https://thefly.com/landingPageNews.php?id=2790623
Karyopharm says updated Phase 2b myeloma med data ‘encouraging’
Karyopharm Therapeutics announced that updated clinical data from the Phase 2b STORM study evaluating selinexor, the company’s lead, oral Selective Inhibitor of Nuclear Export compound, in heavily pretreated patients with penta-refractory multiple myeloma, were presented during an oral session at the Society of Hematologic Oncology 2018 Annual Meeting on September 13, 2018, in Houston. Sundar Jagannath, MD, Director of the Multiple Myeloma Program, Professor of Medicine at Tisch Cancer Institute at Mount Sinai School of Medicine, and principal investigator of the STORM study, presented the data in a session entitled, “Phase 2b Results of the STORM Study: Oral Selinexor plus Low Dose Dexamethasone in Patients with Penta-Refractory Myeloma.” “The additional Phase 2b clinical results presented today are very encouraging for the patients suffering from penta-refractory multiple myeloma and their families. Most notably, the overall response rate for patients treated with oral selinexor and dexamethasone was 26.2% with median duration of response of 4.4 months based on the Independent Review Committee assessment, along with a median overall survival across the entire study of 8.6 months,” said Dr. Jagannath. “Of particular significance, for the nearly 40% of patients who had a minimal response or better, the median survival was 15.6 months, which provided the opportunity for a meaningful clinical benefit for patients on the STORM study with advanced penta-refractory myeloma that is difficult to treat.”
Centene finalizes deal for massive Sacramento campus
Fortune 500 health insurer Centene has finalized a deal to open a major corporate campus in North Natomas and the facility’s developer closed escrow on the site purchase Thursday.
Mayor Darrell Steinberg said Centene will be the tenant in a sprawling headquarters building at East Commerce Way and Arena Boulevard. Steinberg, Councilwoman Angelique Ashby, city officials and the Greater Sacramento Economic Councilnegotiated a deal to lure what will likely become the city’s largest private employer.
Centene already employs about 3,000 people in the Sacramento region and is planning to employ up to 5,000 at its North Natomas campus, city officials said. Construction on the facility could begin as early as next month.
“We are on the verge of the single-largest job creation opportunity we have had in recent history,” Steinberg said.
Sacramento city leaders signed a multimillion-dollar incentive package with Centenenearly a year ago, agreeing to give the company $9,000 for every headquarters job created that is new to the Sacramento area. To qualify for the incentive, the median salary for those positions must be at least $61,515 and the average salary must be above $64,078 a year.
Most positions at the new headquarters would be in health care, accounting and information technology.
“It will be wonderful to watch the buildings rise up, but it will be even better to watch 5,000-plus high-wage jobs move into North Natomas and serve the entire Sacramentoregion,” said Ashby, who represents North Natomas at City Hall.
Natomas Development Partners LLC purchased the 68.2-acre site at East Commerce Way and Arena Boulevard this week, according to developer David Bugatto, who owned the property. Hines Real Estate, the firm seeking to develop the corporate center, is listed as the manager of Natomas Development Partners.
Hines has submitted plans with the city of Sacramento to build five four-story buildings totaling 1.25 million square feet on the site, along with a 17,160-square-foot day care center.
“It’s been a very long process but very satisfying,” Bugatto said. “We’ve been waiting for the right opportunity for our city.”
Glaxo’s ViiV Submits Marketing Application to EMA for HIV Treatment
GlaxoSmithKline said Friday that its majority-owned subsidiary, ViiV Healthcare, has submitted a marketing authorization application for a HIV therapy to the European Medicines Agency.
The U.K. pharmaceutical company said the application was submitted for the combined treatment–consisting of dolutegravir and lamivudine–based on the results of the two Gemini studies that included 1,400 adults with the disease.
“This regulatory submission, if approved, will make available a two-drug regimen option with dolutegravir and lamivudine instead of the traditional three-drug regimen and is an important step in the evolution of HIV treatment,” said Deborah Waterhouse, chief executive officer of ViiV Healthcare.
ViiV Healthcare is majority-owned by Glaxo, with Pfizer and Shionogi Limited also holding stakes.
Novartis, Novo, Glaxo and others hunker down as hurricane sweeps in
As Hurricane Florence bore down on the southeast, drugmakers were taking steps to keep medicine supplies flowing and employees out of harms way.
GlaxoSmithKline closed its inhaler plant in Zebulon, North Carolina, today and said it does not expect to resume operations until Sunday. But the company said it does not expect supply interruptions to patients.
Like all of the other companies contacted, it emphasized the need to protect and support employees. “Our first priority is the health and safety of our employees and continuous supply of medicines to customers,” the company said in an email.
Mary Anne Rhyne, director of corporate communications said, “We have continuity plans in place and they have been activated for our manufacturing plant in Zebulon and our commercial hub in Research Triangle Park.”
The steps were taken as Hurricane Florence was set to make landfall, with winds greater than 120 mph, and rain enough to cause devastating flooding. The hurricane was downgraded on Wednesday from a catastrophic Category 4 with maximum sustained winds of 130 mph to a Category 3 hurricane, with maximum sustained winds of 125 mph, according to the National Hurricane Center, but is still slated to produce “life-threatening” storm surges.
It is the second time in a year that pharma production has been affected by hurricanes after storms wreaked havoc in Puerto Rico last fall.
Novo Nordisk, which is building a massive site API facility in Clayton, North Carolina, where it already has a finished products plant, said it expected the construction site to be closed until at least Friday. The 833,000-square-foot project has a facility footprint of 417,639 square feet, roughly the size of seven football fields. It is located next to the finished products-manufacturing plant that is 457,000 square feet.
“We are monitoring the situation closely, and we have plans in place to ensure continued operation of our critical production areas as long as it is safe to do so,” a spokesperson said today.
Novartis has communicated safety preparations to approximately 2,700 associates and contractors in the storm’s path and has closed a plant in Wilson, North Carolina, that it said last week will be sold to India’s Aurbindo as part of a $900 million deal. The Swiss drugmaker said the site was closed Wednesday evening and plans are to reopen Sunday night and resume production on Monday.
Novartis has shifted product out of potentially impacted areas so that it can can maintain supplies flowing to patients.
In that regard, one plant that is of particular concern to the healthcare system is the Pfizer’s sterile injectables plant at Rocky Mount, North Carolina. U.S. hospitals are already suffering shortages of many sterile injectable drugs, including pain drugs made at another Pfizer plant in McPherson, Kansas. The interruption in supplies of others would be a problem for healthcare providers.
“Pfizer has contingency plans in place to ensure the continuity of supply, and mitigate interruptions during natural disasters,” the company said.
Merck & Co., has three manufacturing facilities in North Carolina located in Durham and Wilson as well as a corporate office in Charlotte. It said a plant in Elkton, Virginia, may also be in the path of the storm. All of the manufacturing facilities in North Carolina and Virginia are shutting down, a spokesperson explained. She said that the company has already adjusted shipments to maintain adequate product supplies and “acquired additional power generators in case they are needed.”
It was the interruption of power that was a huge issue for drugmakers in Puerto Rico last fall when hurricanes ripped through the island. It took months to repair power infrastructure and keeping fuel flowing to power generators also became and issue. Among others, the storm damge interrupted production at three saline plants operated there by Baxter International, adding to a national shortage of the commodity product.
Sun, SPARC Get US FDA OK on Glaucoma, Ocular Hypertension Treatment
XELPROSTM (latanoprost ophthalmic emulsion) 0.005% for topical ophthalmic use is the first and only benzalkonium chloride-free (BAK-free) form of latanoprost
Sun Pharmaceutical Industries Ltd.(Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) and Sun Pharma Advanced Research Company Ltd. (Reuters: SPRC.BO, Bloomberg: SPADV IN, NSE: SPARC, BSE: 532872, “SPARC”) today announced U.S. Food and Drug Administration (USFDA) approval for the New Drug Application (NDA) of XELPROSTM (latanoprost ophthalmic emulsion) 0.005% for the reduction of elevated intraocular pressure (IOP, or pressure inside the eye) in patients with open-angle glaucoma or ocular hypertension. This approval is from Sun Pharma’s Halol (Gujarat, India) facility.
Sun Pharma in-licensed XELPROSTM from SPARC in June 2015 and this approval will trigger a milestone payment to SPARC. SPARC is also eligible for milestone payments and royalties on commercialization of XELPROSTM in the US.
XELPROSTM is the first and only form of latanoprost that is not formulated with benzalkonium chloride (BAK), a preservative commonly used in topical ocular preparations. XELPROSTM is developed using SPARC’s proprietary Swollen Micelle Microemulsion (SMM) technology.
“As the only BAK-free version of latanoprost, XELPROSTM will be an important and alternative treatment option for individuals with open-angle glaucoma or ocular hypertension,” said Abhay Gandhi, CEO, North America, Sun Pharma. “This approval, coming less than one month following the approval of CEQUA™ (cyclosporine ophthalmic solution) 0.09%, reaffirms the strength of Sun Pharma’s fast-growing Ophthalmics division and its commitment to serving the needs of patients with ocular disorders.”
Anil Raghavan, CEO, SPARC said, “Approval of XELPROSTM by USFDA is a significant milestone for SPARC. It is also a validation of our SMM technology which helps to solubilize drugs that have limited or no solubility thus eliminating the need for benzalkonium chloride (BAK).”
In randomized, controlled clinical trials of patients with open-angle glaucoma or ocular hypertension with a mean baseline Intraocular pressure (IOP) of 23-26 mmHg, XELPROSTMlowered IOP by a mean of up to 6-8 mmHg.
XELPROSTM will be commercialized in the U.S. by Sun Ophthalmics, the branded ophthalmic division of Sun Pharmaceutical Industries Ltd.’s wholly owned subsidiary.
Morgan Stanley Global Healthcare Conference Update: Lilly, Amgen, Biogen
As the Morgan Stanley Global Healthcare Conference runs from September 12 through 14, numerous biopharma companies are making presentations, updating their operations and pipeline activities. Here’s a look at some of the highlights.
Eli Lilly and Co.’s senior vice president and chief executive officer Joshua Smiley answeredquestions by Morgan Stanley analyst David Risinger. Unfortunately, due to compliance regulations, they weren’t able to discuss the impending spinout and initial public offering (IPO) of Lilly’s Elanco Animal Health unit. Smiley noted the company has launched nine products since 2014 and they are particularly pleased with its diabetic GLP-1 analog, Trulicity. “And we see a big opportunity in this class,” he said. “The class is growing at about 25 percent, and even with new launches and competition, we continue to see very, very strong growth in the GLPs, and in Trulicity specifically.”
Amgen’s chief executive officer, Bob Bradway, sat down with Morgan Stanley analyst Matthew Harrison. Bradway felt the company was heading into the fourth quarter in a strong position, particularly in terms of long-term growth. He was enthusiastic about Aimovig for migraine, which he said was off to a strong start “because it represents an innovative, effective way to address migraine, a disease for which there wasn’t attractive therapy otherwise available.”
He’s also bullish on their cholesterol drug, Repatha. “And of course,” he said, “we’re excited about what we see happening in our oncology portfolio, not just with Kyprolis in multiple myeloma, but with emerging data in BCMA. We’re excited about what we think we can do with bispecific for CD38 and excited about some of the other agents that we see emerging from our oncology portfolio.”
Bradway also noted Amgen has 10 biosimilars in its pipeline, three of which have been approved. “In aggregate,” he said, “they address a $65 million market opportunity for us. And so we’re excited to be able to begin launching those medicines.” He specifically mentioned Kanjinti, which is already on the market internationally, and Amgevita, its biosimilar for Humira, which is also being marketed internationally.
Biogen’s executive vice president and chief financial officer, Jeffrey Capello, was interviewed by Morgan Stanley analyst Matthew Harrison. Capello noted they were still dominant in multiple sclerosis and are very happy with the performance of Spinraza for spinal muscular atrophy. A bit unusual for Biogen, Capello placed attention on the company’s biosimilars, saying, “We’ve introduced two products now in Europe and we’ve saved the European healthcare system 800 million euros in the last 12 months with one product alone. And so we think that’s very strategic here in Europe and also potentially in the U.S. for the future for us.”
It’s easy to think of Biogen as focused on MS and its high-risk focus on Alzheimer’s disease, but Capello emphasized that they are a neuroscience company, which encompasses more than those two areas, although they are very deep in those areas. “We have eight different areas; four core areas and four emerging areas,” he said, “and they’re not all going to be equal. They can’t all afford to be equal.”
So, on the emerging side, Capello cites pain, ophthalmology, acute neurology, stroke, and acute psychiatry. He feels they are going to require some decision-making on their priorities.
And no discussion with Biogen could ignore Alzheimer’s disease. On BAN2401, Capello didn’t have much to say because Eisai is their partner, and they are leading the clinical program. But Harrison wanted some insight into funding for another big Phase III program in Alzheimer’s. They currently have a large Phase III program for aducanumab, but how much will they invest in the pivotal Alzheimer’s program for BAN2401?
Capello said, “I don’t think we’re fazed about having multiple programs and funding multiple programs. With our partnership with Eisai, we each fund roughly 50 percent of those programs. So we have an opportunity to share the cost with our partner. It affords us the opportunity to do more and have more shots on goal with the view that if we end up with a couple of products that work, that’s fantastic.”
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