Illumina announced that it acquired Edico Genome. Edico Genome’s Dragen Bio-IT Platform uses field programmable gate array technology in conjunction with proprietary software algorithms to reduce both data footprint and time to results. Dragen can be run on premise, in the cloud, or in a hybrid mode, and is flexible and compatible for use with multiple cloud storage solutions and analysis pipelines. Edico Genome has built a strong base of NGS customers who have incorporated Dragen as a standard part of their sequencing workflow. The Dragen platform complements Illumina’s sequencing portfolio and enables customers to benefit from reduced investment in compute infrastructure, and accelerated result times, to improve their overall efficiency and to allow greater emphasis on interpretation and reporting.
Tuesday, May 15, 2018
Albertsons, Rite Aid to Host Analyst Presentation
Albertsons Companies, Inc. one of the nation’s largest grocery retailers, and Rite Aid Corporation (NYSE:RAD), one of the nation’s leading drugstore chains, announced today that they will host a joint analyst event on May 15, 2018. The management teams of both companies will discuss the strategic and financial benefits of the proposed merger transaction between Albertsons Cos. and Rite Aid.
As previously announced on February 20, 2018, Albertsons Cos. and Rite Aid announced a definitive merger agreement under which privately held Albertsons Cos. will merge with publicly traded Rite Aid.
In-person attendance is by invitation only; however, the event will be webcast live beginning at 9 a.m. until approximately 2 p.m. ET. The webcast can be accessed in the Investor Relations sections of www.albertsonscompanies.com and www.riteaid.com, along with an accompanying presentation and will be available for replay until the Rite Aid special stockholders meeting.
Valeant upped to buy by Mizuho
Mizuho Securities upgraded Valeant Pharmaceuticals (NYSE: VRX) from Neutral to Buy with a price target of $27.00 (from $15.00), ‘acknowledge turnaround.’
Get Docs Out of Drug-Buying Business, HHS Chief Urges
Doctors should get out of the business of making money off of providing prescription drugs to Medicare beneficiaries, Health and Human Services Secretary Alex Azar said Monday.
Currently, physicians who administer drugs paid for under Medicare Part B — which covers drugs administered in the physician’s office — pay for the drug themselves up front and then are reimbursed at the average sales price plus a 6% markup. This system “gets into the notion of physicians or facilities making money off the arbitrage between acquisition price and reimbursement,” Azar explained at a briefing with reporters following a speech he gave on President Trump’s plan to lower the cost of prescription drugs.
Instead, the administration is proposing a “competitive acquisition program” for Part B drugs.”The concept of the competitive acquisition program is not to have physicians take title to the medications they’re administering, but rather, have a competitive program where those drugs would be purchased and the capital outlay would occur elsewhere,” so the doctor doesn’t have to buy the drug “and the physician is paid … a fair, appropriate level of reimbursement for their services in administering the drug,” Azar said.
The idea of such a program isn’t entirely new. “We believe the market has developed sufficiently in terms of the power and scale of group purchasing organizations, specialty pharmacies, specialty distribution [companies] and pharmacy benefit managers that there are now plenty of players in the space compared to when this was tried over a decade ago,” Azar said. The current players “could actually execute a program like this well, secure substantial discounts, and work effectively with physicians for whom the ‘buy-and-bill’ model doesn’t make sense, and that’s even assuming it’s done as a voluntary program,” he added.
The current Part B reimbursement system has other problems besides the physician purchase issues, Azar said. “Right now in Part B, essentially as soon as a drug is approved by the FDA, it’s covered,” Azar explained in his speech. “Medicare gets a bill for the drug, composed of the standard price plus a 6% markup, and we pay it. Compare that with the negotiation in Part D: Plans determine whether a drug should be covered or whether an alternative is superior. Plans negotiate discounts, rather than just paying full price.”
“You can imagine what happens when you’re developing a drug: It’s often much more appealing for the drug to go into Part B than D,” he added. And with doctors buying the drugs themselves and then awaiting reimbursement, there’s another problem: “Some of the price tags are approaching half a million dollars, which is also an issue for physicians if they don’t want to make that investment up front,” said Seema Verma, administrator of the Centers for Medicare & Medicaid Services, at the briefing, during which public affairs representatives were also present. “[And] I don’t think part B envisioned paying 6% on top of a half-million-dollar drug.”
HHS officials also are considering moving some or all Part B drugs into the Medicare Part D program as a way of negotiating more competitive prices, Azar said. “One approach is to move them all [into Part D, but we are also] going to be conducting … an up-to-date study of U.S. pricing and negotiations for Part B drugs, and we might highlight drugs where we are getting a worse deal compared to other industrialized nations,” and maybe conduct a pilot program for purchasing those drugs.
Another possibility would be “to focus on classes where there are drugs within [parts] B and D with a high spend where it would be particularly fruitful to combine B and D to get rid of any perverse incentives around prescribing behavior,” said Azar.
Azar’s speech on Monday was a follow-up to remarks he gave Friday after Trump broadly outlined the administration’s plan, which included four strategies:
- Increasing competition in the prescription drug marketplace
- Changing the way drugs are paid for under Medicare Part B
- Increasing incentives to lower “list prices” for drugs
- Changing the system of drug rebates
Azar used part of his talk on Monday to fight back against the perception that the administration was waffling on its earlier promises to allow Medicare to negotiate with drugmakers directly for lower prices for drugs used by Medicare beneficiaries.
“You’ve probably heard before that Medicare could save tons of money by negotiating directly for drugs,” he said. “This just isn’t true, and you don’t have to take my word for it. The Congressional Budget Office found [several years ago] that the idea of direct negotiation would generate almost no savings. The same conclusion was reached by President Obama’s Office of Management and Budget when it assessed the proposal in his budget.”
“The only way that direct negotiation saves money is by doing something this administration does not believe in: denying access to certain medicines for all Medicare beneficiaries, or setting prices for drugs by government fiat,” Azar continued. “We don’t believe either of these proposals would put American patients first. They would move us toward the kind of socialized medicine systems that have such a notorious reputation for poor quality and access.”
Officials also were focused Monday on ways to increase generic competition for brand-name drugs. “In one of the most notorious examples, pharma companies use FDA safety rules or commercial distribution restrictions to block generic drug manufacturers from having access to samples of the branded drug,” said Azar during his speech. “Those samples are needed to perform the testing that gets generic drugs approved, giving consumers safe and effective lower-cost medications.”
“We know that certain brand-name manufacturers are abusing the system by blocking access to samples, and hiding behind FDA’s rules when they do it … FDA is going to begin publicly identifying drug companies suspected of engaging in these abusive practices.”
3 Companies with FDA Decisions in the Next Week
There are a few upcoming approval dates for several companies this week. Let’s take a look at the companies and their products awaiting approval.
- Evolus. Evolus’s prabolutinumtoxinA for severe glabellar lines—better known as “frown lines”—has a PDUFA date of May 15. On April 5, 2018, the company, located in Irvine, California, presented results of its Phase III head-to-head comparative trial of EVB-003 at the 2018 Aesthetic & Anti-Aging Medicine World Congress (AMWC) held in Monte-Carlo, Monaco. It expanded upon data presented in February at the American Academy of Dermatology (AAD) meeting. Evolus’ product was compared to Allergan’s Botox (onabotulinuymtoxinA), where it showed “non-inferiority.” The product is also under review by the European Medicines Agency (EMA).
- Amgen. Amgen’s Aimovig for migraine has a PDUFA date of Thursday, May 17. The FDA accepted Amgen’s Biologics License Application (BLA) for Aimovig (erenumab) for review on July 20, 2017. The drug is for the prevention of migraine in patients that experience four or more migraine headaches per month. If it’s approved, it is expected to be the first-and-only monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor, designed specifically for the prevention of migraine.
The application was based on pivotal trials of more than 2,600 patients having four or more days of migraine per month. Phase II and III trials of the drug compared to placebo showed a reduction in the number of migraine-affected days, disability and acute medication use for patients. The safety profile was similar to placebo.
Aimovig decreased migraine days by about 50 percent in about a third of patients receiving it. In the Phase IIIb LIBERTY trial, 246 patients who had two to four previous treatments that didn’t work were randomized to receive monthly subcutaneous injections of either 140 mg of Aimovig or placebo for 12 weeks. Patients receiving Aimovig also met all secondary endpoints, including reduction in monthly migraine days, decreased migraine-specific drug use per month, a reduction of 75 percent or more in monthly migraine days, and a 100 percent reduction in monthly migraine days.
If approved, Amgen and its partner Novartis will co-commercialize the drug in the U.S. Amgen holds exclusive commercialization rights to it in Japan, and Novartis has exclusive rights to commercialize it in the rest of the world.
GlobalData, an analytics company, projects that CGRP antibodies such as Aimovig, will create combined sales of $4 billion by 2026.
Although Amgen and Novartis are ahead in this market, several other companies are focusing on it as well. These include Eli Lilly’s galcanezumab, Teva Pharmaceuticals’ fremanezumab and Alder BioPharmaceuticals’ eptinezumab.
- Dova Pharmaceuticals. And coming up on Monday, May 21, the FDA is expected to make a decision on Dova Pharmaceuticals’ New Drug Application (NDA) for avatrombopag for thrombocytopenia in patients with chronic liver disease (CLD) who are scheduled to undergo a procedure. The submission was built on two identically-designed Phase III clinical trials, ADAPT 1 and 2. Avatrombopag met all primary and secondary endpoints with high statistical significance.
The application was accepted under a Priority Review status, which moved the review time from 10 months to a goal of six months. The drug is a second generation orally administered TPO-RA.
In a November 2017 statement, Alex Sapir, president and chief executive officer of Dova, said, “We are extremely pleased that FDA has accepted our NDA submission with Priority Review. We believe that avatrombopag represents a novel treatment option with robust efficacy as well as an improved safety profile when compared to platelet transfusions, today’s current standard of care. We look forward to working closely with FDA through the review process.”
Pfenex Has Positive Osteoporosis Study; On-Track for Submission of NDA in Q3
Pfenex Inc. (NYSE American: PFNX), a clinical-stage development and licensing biotechnology company focused on leveraging its Pfēnex Expression Technology® to improve protein therapies for unmet patient needs, today announced top-line results from its PF708-301 study, which showed comparable overall profiles between PF708 and Forteo® after 24 weeks of daily injection in osteoporosis patients. Pfenex expects to submit an New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the third quarter of 2018.
“We are pleased with the results of the PF708-301 study, which show comparable overall profiles between PF708 and Forteo,” said Eef Schimmelpennink, Chief Executive Officer of Pfenex. “We expect that these results from the PF708-301 study, along with the previously announced bioequivalence findings from the PF708-101 study in healthy subjects, will support the PF708 NDA submission. We are on-track for submission to the FDA in the third quarter of 2018, with a potential commercial launch in the United States as early as the third quarter of 2019, subject, of course, to FDA approval of the application.”
PF708 is a teriparatide drug candidate that is being developed as a therapeutic equivalent to Forteo, which is approved and marketed by Eli Lilly for the treatment of osteoporosis patients at a high risk of fracture. PF708 is being developed pursuant to the 505(b)(2) regulatory pathway in the United States and references Forteo as the Reference Listed Drug.
BeiGene started at buy by Credit Suisse
Credit Suisse issued an “outperform” rating on BeiGene Ltd. (Nasdaq: BGNE) today, raising the price target to $230.20 per American depositary share.
Responding to the high rating, the stock of the company soared nearly 11 percent to $192.62 per share in early trading on Monday.
The Chinese biopharmaceutical firm develops and markets immune-oncology drugs and has headquarters in Beijing and Cambridge, Massachusetts.
BeiGene issued its quarterly earnings results last Wednesday. The company reported net loss of $105.1 million, or a $2.03 loss per ADS for the first three months, compared with last year’s loss for the same period of $50.6 million, or $1.27 per share. The expenses for the quarter nearly tripled last year’s at $143.4 million, attributable to the company’s expansion. Revenue for the quarter nearly doubled analysts’ estimates and grew to $32.5 million from zero in the first quarter of last year.
“We continue to make great progress launching new clinical trials on a global scale for patients with a wide variety of cancers, where we believe our investigational treatments can have a profound impact,” founder and chief executive officer of BeiGene, John Oyler, said in a statement.
“Given the significantly reformed regulatory environment in China, as well as important additions to our senior leadership team highlighted by the appointment of Dr. Xiaobin Wu as our General Manager of China and President of BeiGene, Ltd., we are excited about our China and global prospects,” Oyler said.
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