Plaintiffs Allege Mylan Suppressed Evidence in EpiPen Suit
On Monday, lawyers for the plaintiffs in the proposed class action accusing Mylan of engaging in an unlawful scheme to boost sales for its EpiPen allergy treatment asked a federal judge to sanction the drugmaker for allegedly interfering with discovery and withholding documents and emails.
The plaintiffs stated that without their knowledge Mylan had reached out to vendors they subpoenaed and forced them to withhold various documents that Mylan believed to be “privileged”. The filing states that vendors provided “marketing, promotion, contracting, pricing or business strategy services” for the company and that they only found out after noticing a missing document. After asking one of the vendors about the missing document, they were told that Mylan had asked for it to be withheld. The plaintiffs then contacted Mylan’s attorneys who responded that the vendors had the right to determine which documents to submit and which to hold back.
The plaintiffs are requesting a court order stating that Mylan has “waived any claim of privilege” over the vendors’ documents. The attorneys also want the company to “provide full details of all” documents affected and for the company to reimburse certain attorney fees.
DOJ Gives Preliminary Approval to CVS/Aetna Merger
On Wednesday, CVS Health announced that it has received DOJ clearance allowing it to proceed with its proposed acquisition of Aetna. This clearance is a key milestone toward finalizing the transaction and the acquisition is expected to close during the fourth quarter of 2018.
The approval comes just days after Aetna announced on September 27 that it reached an agreement to sell its Medicare Part D drug plan business to WellCare Health Plans for an undisclosed amount. Regulators were concerned about the overlap between CVS’ and Aetna’s Medicare Part D plans. The Justice Department said that the divestiture was a condition to winning final approval.
“DOJ clearance is an important step toward bringing together the strengths and capabilities of our two companies to improve the consumer health care experience,” said CVS Health President and Chief Executive Officer Larry J. Merlo. “We are pleased to have reached an agreement with the DOJ that maintains the strategic benefits and value creation potential of our combination with Aetna. We are now working to complete the remaining state reviews.”
Merlo added that “CVS Health and Aetna have the opportunity to combine capabilities in technology, data and analytics to develop new ways to engage patients in their total health and wellness. Our focus will be at the local and community level, taking advantage of our thousands of locations and touchpoints throughout the country to intervene with consumers to help predict and prevent potential health problems before they occur. Together, we will help address the challenges our health care system is facing, and we’ll be able to offer better care and convenience at a lower cost for patients and payors.”
CVS Health announced in December that it would buy Aetna for approximately $69 billion in cash and stock. The deal combines CVS pharmacies with Aetna’s insurance business. CVS also has one of largest pharmacy benefits managers through CVS Caremark and a major Medicare Part D plan sponsor through its SilverScript unit.
Several Pharmaceutical Companies Adding Digital Executives
On Wednesday, Merck announced they had hired Jim Scholefield as chief information and digital officer. He will be responsible for leading Merck’s information technology and digital strategy and will be a member of the company’s executive committee. Scholefield was previously employed by Nike and his resume includes spearheading a “digital transformation” while there.
“His extensive experience leading large global IT organizations for multinational companies, including developing innovative digital capabilities, makes him an exceptional addition to our team,” Robert Davis, Merck’s CFO and executive vice president of global services, said in the statement.
Pfizer, Novartis, and GlaxoSmithKline have also all recently recruited consumer executives for their digital teams.
Earlier this month, Pfizer announced that they had appointed Lidia Fonseca, who currently serves as Quest Diagnostics’ chief information officer, as their chief digital officer. They stated that she will be “responsible for creating and implementing a strategy that accelerates and improves our digital capabilities so we can deliver more value to patients.”
Last August, Novartis brought in Bertrand Bodson from the retail industry to head up its digital efforts and in March promoted him to the executive committee, citing digital and data as top priorities.
Also last year, GlaxoSmithKline hired Karenann Terrell, a former Walmart Store executive, as chief digital and technology officer to help the company harness IT and digital to augment its own transformation. She is responsible for developing GSK’s digital, data, and analytics strategy.
Digital developments will continue to be of utmost importance for pharmaceutical companies as it gives them the ability to deliver more personalized patient care; engage more fully with physicians and patients; use data to drive superior insight and decision making; and transform business processes to provide real-time responsiveness.
AstraZeneca Strengthens Cancer Focus with Stake in Innate
On Tuesday, AstraZeneca announced a multi-term agreement with Innnate Pharma, a French biotech company, known for its cancer immunotherapy. The agreement builds on an existing collaboration, aimed at accelerating each company’s oncology portfolio and bringing new medicines to patients more quickly. The collaboration will enable Innate to develop its commercial footprint and strengthen its ability to invest in its immuno-oncology (IO) pipeline and R&D platform and will also enrich AstraZeneca’s IO portfolio with preclinical and clinical potential new medicines.
Under the deal, AstraZeneca will obtain full oncology rights to an antibody, monalizumab, which in combination with another drug had already been shown to be effective in treating head and neck cancer and has demonstrated potential in colorectal cancer.
AstraZeneca additionally obtains option rights for co-development and co-commercialization of a CD39-targeting antibody called IPH5201, along with four of Innate’s preclinical molecules.
Innate will in turn license the US and EU commercial rights to AstraZeneca’s recently FDA-approved Lumoxiti for hairy cell leukemia, a rare blood cancer.
AstraZeneca CEO Pascal Soriot said: “Our expanded collaboration with Innate Pharma enables us to further strengthen our leadership in immuno-oncology, and to explore the potential of next-generation immuno-oncology pathways, together with the world-class scientific team of Innate.”
“This is a defining moment for us,” said Innate CEO Mahjoubi. “It really means the dream has become true and the company now is a fully integrated biotech with an opportunity to commercialize a major innovative treatment.”
FDA Approves Invokana for CV Protection
On Tuesday, Johnson & Johnson announced that the FDA approved an expanded indication for Invokana to reduce the risk of major cardiovascular (CV) events, including myocardial infarction, stroke or death due to a CV cause in adults with type 2 diabetes who have established CV disease. Invokana, a member of the SGLT2 class, is the first and only oral diabetes treatment approved with this indication.
Invokana was first approved in 2013 as a boost to diet and exercise for glycemic control in diabetes. The drug received the expanded indication based on the 10,000-person CANVAS trial that showed the cardiovascular benefits of canagliflozin in a population with type 2 diabetes that either had established cardiovascular disease or had two or more risk factors for it.
“This FDA approval makes Invokana the only oral type 2 diabetes treatment indicated to reduce the risk of heart attack, stroke or CV death. It is an important step forward for patients and the physicians who treat them,” said James List, M.D., Ph.D., global therapeutic area head, cardiovascular & metabolism, Janssen Research & Development, LLC. “Not only does Invokana enable patients to control their diabetes symptoms by lowering their A1C levels, but it now also helps protect them from potentially devastating cardiovascular events.”
“Americans living with type 2 diabetes are two to three times more likely to die from heart disease than adults without diabetes,” said Ralph DeFronzo, M.D., professor of medicine and chief of the Division of Diabetes at University of Texas, Health Diabetes Center, San Antonio.4 “With this approval, Invokana now plays an even more important role in the overall treatment mix with its demonstrated ability to reduce the risk of potentially devastating cardiovascular events.”
AstraZeneca to Sell Drug Rights to Covis Pharma
On Wednesday, AstraZeneca announced that it had agreed to sell its rights to asthma drug Alvesco and nasal sprays Omnaris and Zetonna to Covis Pharma for $350 million. The rights being divested by AstraZeneca cover markets outside the US and the US royalties for the three drugs.
Currently, Covis Pharma commercializes Alvesco, Omnaris and Zetonna in the US and following the closing of the latest deal, will become the owner of the drugs.
This follows last week’s decision by AstraZeneca to sell its Nexium rights in Europe and its Vimovo rights worldwide to Grünenthal in exchange for up to $922 million.
With the deals, AstraZeneca is seeking to scale down in non-core therapeutic areas, generate cash from older medications, and put its resources behind key franchises in oncology, cardiovascular and metabolic disease, and respiratory ailments.
“One of our strategic objectives is to divest parts of our portfolio, allowing us to allocate resources to develop innovative new medicines to address unmet patient needs. Covis Pharma has strong capabilities in marketing medicines around the world, and our agreement with them means patients will continue to benefit from Alvesco, Omnaris and Zetonna.” Said Mark Mallon, AstraZeneca’s global product and portfolio strategy executive vice president.
Covis Pharma CEO Michael Porter said: “This is an exciting milestone for Covis Pharma and aligned with our strategy to build a global respiratory/allergy franchise. When we acquired the US rights for Alvesco, Omnaris and Zetonna in 2017, we recognized the importance of these medicines in the respiratory and allergy therapeutic area and we look forward to extending our reach to meet the needs of patients and physicians around the world.”
Pfizer Raising Drug Prices in 2019
Last Friday, Pfizer announced plans to raise prices on 41 of its drugs in January. The manufacturer said it would raise the list price of all but four of the drugs by 5%; three drugs will increase 3%; and one will go up by 9%. These drugs represent 10 percent of Pfizer’s drug portfolio, and the company says the price hikes will be offset by higher rebates and discounts offered by pharmacies and insurance companies.
The company did not disclose which drugs are getting price increases effective January 15, 2019.
The price increases come after Pfizer’s decision this summer to raise prices on roughly the same number of medicines. The news caught the attention of President Donald Trump, who tweeted that the drugmaker “should be ashamed” and pledged a response from the government. Later, Trump and HHS secretary Alex Azar spoke with Pfizer CEO Ian Read, and the company agreed to delay its price hikes.
At the time, Pfizer stated that the deferral would be temporary, lasting only until the end of the year or until Trump’s blueprint went into effect, whichever came sooner. They were referring to the Trump administration’s 44-page “blueprint” for increasing competition, reducing regulations and changing the incentives for all players in the drug industry which was introduced in May.
“We believe the best means to address affordability of medicines is to reduce the growing out-of-pocket costs that consumers are facing due to high deductibles and co-insurance, and ensure that patients receive the benefit of rebates at the pharmacy counter,” Ian Read, Pfizer’s chief executive officer, said in a statement.
Pfizer Wins Big With Lyrica Patent Extension
On Tuesday, the FDA approved Lyrica for use in patients with pediatric epilepsy. The drug’s patent was originally set to expire by end of this year, but this new indication puts that date to the end of June, 2019. Lyrica is also indicated for fibromyalgia, neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia and neuropathic pain associated with spinal cord injury.
Mylan Wins Patent Lawsuit with Sanofi Over Insulin Patent
On Thursday, Mylan announced that the U.S. Patent and Trademark Appeal Board (PTAB) had ruled in its favor and found all claims of Sanofi’s Lantus formulation unpatentable. The decision comes approximately 18 months after Mylan filed petitions for a review of the two patents.
Mylan and its partner Biocon currently have a new drug application pending review for generic versions of Lantus.
Lantus is a long-acting insulin used to treat adults with type 2 diabetes and adults and pediatric patients with type 1 diabetes for the control of high blood sugar. Sanofi sells Lantus both in vials and as a disposable injection pen.
Mylan CEO Heather Bresch said, “For years, Mylan has been investing in the development of a more affordable generic to insulin glargine for diabetes patients. The PTAB’s favorable ruling that invalidates two Sanofi Lantus formulation patents is an important step forward in our journey to help address the needs of nearly 30 million Americans living with diabetes. We take seriously the responsibility to improve insulin access and are honored to be a part of the solution that will bring much-needed competition to this critical market.”
Sanofi filed a patent infringement case against Mylan in October 2017, which remains pending in the U.S. District Court for the District of New Jersey. Due to the ongoing litigation, approval of Mylan and Biocon’s copycat is subject to a 30-month stay which extends to early 2020.
“We believe that it is unlikely that the Patent Trial and Appeal Board (PTAB) ruling on the formulation patents will have an impact on Mylan’s timing for a launch of its glargine products,” a Sanofi spokesman said in an emailed statement.
Drug Companies Raising Prices in January
Twenty-eight drugmakers including Allergan, Amgen, AstraZeneca, Bayer, Biogen, GlaxoSmithKline, and Novartis, have taken steps to raise the U.S. prices of their medicines in January, ending a self-declared halt to increases made by the pharmaceutical industry under pressure from the Trump administration. Pfizer had previously announced plans to hike prices on 41 of its drugs in mid-January.
The drugmakers filed notifications with California agencies in early November disclosing that they planned to raise prices in 60 days or longer. Under a state law passed last year, companies are required to notify payers in California if they intend to raise the U.S. list price on any drug by more than 16 percent over a two-year period.
The documents filed indicate that the companies plan to increase prices as early as January 1.
Novartis is planning to raise prices on more than 100 indications of over 30 different drugs in January, the documents show, with increases ranging from 4.5 percent to 9.9 percent. Drugs on the list include multiple sclerosis drug Gilenya, psoriatic arthritis treatment Cosentyx, leukemia treatment Tasigna, and blood pressure treatment Diovan.
Novartis spokesman Eric Althoff said the company plans to raise U.S. list prices on 14 percent of the medicines it sells in the country in 2019, for an average increase of 4.7 percent on those drugs.
“Our rebates and discounts, however, continue to grow even faster,” Althoff said. As a result, the company expects a net price decrease of nearly 5 percent across the whole U.S. portfolio, he said.
Bayer filed notifications with California agencies to increase prices on six of its drugs in January, many of which are birth control products. Most of these price increases are 5 percent.
Bayer said that the U.S. wholesale price of its products are not representative of what most consumers pay and that “list price increases are expected to be offset by higher rebates and discounts paid to insurance companies and pharmacy benefit managers.”
Cigna and ESI Merger is Finalized
On Thursday, Cigna closed on its deal to acquire healthcare giant Express Scripts, combining a health insurer with a company that manages prescription drug benefits.
The deal which was originally announced in March, received approval from the Department of Justice in October but still needed key state insurance agencies to sign off. On December 18, the companies received the final regulatory approvals needed to close the deal.
“Today’s closing represents a major milestone in Cigna’s drive to transform our health care system for our customers, clients, partners and communities,” David Cordani, Cigna CEO, said in a statement. “Together, we are establishing a blueprint for personalized, whole person health care, further enhancing our ability to put the customer at the center of all we do by creating a flexible, open and connected model that improves affordability, choice and predictability.”
“As we launch our combined company, we have a highly-accomplished and experienced enterprise leadership team in place to guide our team around the world,” said Cordani. “We are excited about the opportunities to transform the health care system and improve societal health through our combination.”
Amazon Planning to Utilize EHR for a Smarter Direct to Consumer Process
Last Tuesday, Amazon announced the company is selling new software designed to mine medical data in electronic health records (“EHRs”) to provide physicians and hospitals with information they could use to reduce costs and improve care.
Additionally, Amazon’s has recently discussed they are considering implementing trials that use EHR to enable doctors to “prescribe” off-the-shelf medical products. They would include buy links to Amazon.
Pharma has already been utilizing this technology as doctors have been evaluating branded drugs and messages inside EHRs and sending prescriptions to retail pharmacies for a while. However, it could have future implications for the industry in Amazon prescription sales via its recent PillPack pharmacy acquisition. The amount of patient data held within digital medical records is of increasing importance within the healthcare space.
Angelo Campano, Ogilvy Health VP, customer experience in EHR, said his group worked with Amazon on a project from August 2017 through January 2018 that used its technology to mine EHR record information. The Amazon tool, which didn’t have a name at the time, could search an integrated central database of EHR information to look for specific patients—in this case, people potentially undiagnosed for a particular kind of narcolepsy. The information would then be relayed to the pharma company to create smarter DTC ads to those personally de-identified (but locatable) patients, as well as to target doctors for potential sales visits.
“If I’m a patient and I have six doctors, each one has a different EHR about me and they don’t necessarily talk unless they’re in the same health system,” Campano said. “So it gives the patient the ability to go to a doctor who doesn’t have access to their information and show them their history of previous interactions and keeping it consistent from physician to physician.”
Most EHR includes branded drug information along with patient-specific details such as availability and cost under their insurance coverage.
“That’s the point that Apple and Amazon are trying to get to—all digital system for scripts, retail and data gathering,” Campano said.