Updated Mylan Statement on U.S. Supply of EpiPen

Our manufacturing partner Meridian Medical Technologies, a Pfizer company, continues to experience interruptions in the production of EpiPen® (epinephrine injection, USP) 0.3 mg and EpiPen Jr® (epinephrine injection, USP) 0.15 mg Auto-Injectors. Over the past few months, there has been intermittent supply of EpiPen at wholesalers and pharmacies. We are actively exploring several options with Pfizer that would help stabilize supply. We will continue to provide updates, including timing for resolution, as we receive them from Pfizer.

Pfizer’s statement is available here.

We appreciate how important it is for individuals with life-threatening allergies to have access to epinephrine auto-injectors, and understand the challenges this situation continues to pose for patients. Pfizer is working hard to increase production and stabilize supplies, but until this occurs, supplies of EpiPen® 0.3 mg and EpiPen Jr® 0.15 mg Auto-Injectors, and the authorized generic versions of these strengths, will continue to vary from pharmacy to pharmacy and may not always be available.

Our priority is to ensure patients with a life-threatening allergy have access to epinephrine auto-injector products. For our part, we are expediting shipments upon receipt from Pfizer. We also are working closely with Pfizer to stay informed of anticipated shipments and are maintaining regular dialogue with health authorities to provide frequent updates on supply status.

We continue to encourage patients to call our Mylan Customer Relations at 800-796-9526 for assistance in locating alternative pharmacies. The team has successfully located product for patients who are experiencing difficulty accessing their prescription. To further assist patients during this period of limited supply, we recently extended our Customer Relations hours to Monday through Friday, 8 a.m. to 7 p.m. ET.

To support patient access to the product during this supply constraint, we are encouraging healthcare professionals to manage prescription renewals diligently.

https://bit.ly/2vtldcl

Hack of Medtronic pacemaker shown off at security conference, CNBC says

CNBC’s Sally Shin, reporting from the Black Hat USA conference, shared a picture of hackers who were able to hack into a Medtronic pacemaker.

https://bit.ly/2M2faWz

UnitedHealth is buying pharmacy operator Genoa

Health insurer UnitedHealth has at least a tentative agreement to buy specialty pharmacy operator Genoa Health from private equity firm Advent International, Axios has learned from a source familiar with the deal.

Bottom line: UnitedHealth is basically seeking to control a specialty channel by buying Genoa, whose 400 full-service pharmacies are located within community mental health centers.

• We also hear that Genoa CEO John Figueroa will move on, with Genoa chief commercial officer Mark Peterson running the business for UnitedHealth.
• Bloomberg yesterday reported that the sale price could be over $2 billion, but without naming UnitedHealth (instead it reported Walgreens as a possible suitors). No comment from any of the involved parties.
• This is part of a broader trend of pharmacy/health insurer tie-ups, such as CVS buying Aetna.

https://bit.ly/2vPi0mx

Rockwell reaches settlement with former executives, Board members

Rockwell Medical Inc. announced on Aug. 7 it had entered into a settlement agreement with former company CEO Robert Chioini, chief financial officer Thomas Klema, and former Board members Patrick Bagley and Ronald Boydafter members of the company’s Board of Directors clashed with the executives over running the company and forced Chioini to resign in May.

Five members of the Rockwell Medical Board of Directors – Benjamin Wolin, Mark Ravich, John Cooper, Robin Smith and Lisa Colleran – were named in the settlement, according to a company press release. The company said specific terms of the agreement, which is effective immediately, are confidential, but includes the following:

Chioini and Boyd resigned from the company’s Board of Directors.

The parties to the agreement mutually released one another from all claims through the date of the settlement agreement.

A pending federal lawsuit filed by the Board against Chioini, Klema, Boyd and Bagley will be dismissed.

For approximately five years, the parties will not directly or indirectly attempt to participate in the management or operations of Rockwell or its affiliates or subsidiaries.

Rockwell will pay Chioini and the other executives $1.5 million, $750,000 of which was paid upon the execution of the agreement and nine monthly installments of $83,333 each, with the last installment being paid in May 2019. Rockwell will also pay Boyd an additional $30,000.

Chioini and Klema agreed to forfeit 313,600 unvested shares of common stock that had been issued in March 2017 as a performance-based award.

Rockwell Medical Board chair Wolin said in a prepared statement that “We are pleased to have entered into this Agreement, which we view as in the best interest of all our stakeholders. With these matters now firmly behind us, the Board and management team will focus on executing on the Company’s near- and long-term objectives to realize the potential of our innovative renal drug therapies and drive value for our shareholders.”

Rockwell will hold a conference call on Aug. 14 at 5:00 pm EST to discuss the company’s current financial performance.

https://bit.ly/2vQzMWu

Collins booted from Energy & Commerce panel amid insider trading charges

Hours after federal prosecutors indicted Rep. Chris Collins on Wednesday on a charge of insider trading of stocks, House Speaker Paul Ryan said the congressman will not serve on a key health committee until the case is resolved.

The New York Republican, who has led the charge to try to reform the 340B drug discount program as a member of the House Energy & Commerce Committee, was indicted Wednesday. Prosecutors allege that Collins, who sat on the board of the Australian biotechnology company Innate Immunotherapeutics, passed along nonpublic information about a key trial of its multiple sclerosis drug. Collins’ son Cameron Collins and Stephen Zarsky, father of Cameron Collins’ fiancee, and unnamed defendants were also indicted.

The indictment filed in a federal court in New York alleged that the congressman learned about a failed drug trial because of his position on Innate’s board and he passed the information on to his son, who then sold off his own stocks before the public disclosure of the trial sent stocks plummeting.

The congressman did not sell his own significant share of stocks, and prosecutors allege he was “virtually precluded from trading his own shares for practical and technical reasons.”

One of those reasons was the ongoing House ethics investigation into Collins’ role with Innate, according to the indictment. The Office of Congressional Ethics last fall recommended that the House Ethics Committee review allegations of inappropriate use of nonpublic information for purchasing Innate stock. However, prosecutors claim that Collins’ alleged tip to his son spurred a sell-off by the other defendants. Collins’ own stocks lost millions of dollars in value.

Ryan in his statement said the House Ethics Committee should run a “prompt and thorough investigation” into the allegations.

“Insider trading is a clear violation of public trust,” Ryan said. “Until this matter is settled, Rep. Collins will no longer be serving on the House Energy and Commerce Committee.”

Collins has been a key driver of the panel’s proposed reforms to the 340B drug discount program, and his removal comes as committee lawmakers consider a set of major bills just introduced last month. Collins introduced the “patient definition” bill that would mandate hospitals tie their significant outpatient drug discounts to low-income patients. The bill includes carveouts for vulnerable hospitals.

Collins was also the first member of Congress to endorse President Donald Trump’s candidacy and served as Trump’s congressional liaison during the transition.

His indictment carries reverberations of the controversy that plagued former HHS Secretary Tom Price after his 2016 nomination. Collins had invited Price to buy stock in Innate Immunotherapeutics at a discount only available to select U.S. investors. Price ultimately divested from the company over the course of his embattled confirmation process.

Attorneys for Collins pushed back against the indictment and said they would “mount a vigorous defense to clear his good name.”

“It is notable that even the government does not allege that Congressman Collins traded a single share of Innate Therapeutics stock,” Jonathan Barr and Jonathan New of the firm Baker Hostetler said in a statement. “We are confident he will be completely vindicated and exonerated.”

Collins’ lawyers added that the congressman will say more later on Wednesday.

The Office of Congressional Ethics in October 2017 urged a deeper look at the case “because there is a substantial reason to believe that Representative Collins shared material nonpublic information in the purchase of Innate stock, in violation of House rules, standards of conduct, and federal law.”

However, the board also recommended that the ethics committee dismiss the allegation that Collins purchased the stock at a discounted rate offered to him because of his status as a congressman. The same allegation had been levied against Price.

https://bit.ly/2AU19Vr

Fast-growing job categories in healthcare come with varied salaries

Healthcare managers, physicians and nurses seem to get all the attention regarding job growth and salaries, but there are a lot of occupations with varying degrees of expected growth and salaries. Download the PDF.

https://bit.ly/2AUr0N8

BeiGene hit after historic $903M Hong Kong IPO with negative biotech sentiment

The first day of its secondary listing in Hong Kong has proven slightly disappointing for BeiGene.

The Beijing-based cancer drugmaker closed its trading debut down 1% after falling as much as 5% during the day. Despite recruiting eight heavyweight investors to cement its whopping $903 million IPO, BeiGene failed to stir up excitement in the retail tranche, which made up 9% of the total shares offered.

Meanwhile, the cornerstone investors — including New York-based hedge fund Baker Bros Advisors, Singapore’s sovereign wealth fund GIC, and two of China’s most influential biotech VCs, Hillhouse Capital Management and Ally Bridge — collectively bought 31% of the international shares.

BeiGene — a tremendous Nasdaq success that’s trading at over seven times its listing price — said it’s “satisfied” with how its secondary listing turned out.

“Through the Hong Kong listing, we have met our main objectives of increasing our visibility and expanding our shareholder base in Asia, especially long-term investors,” CFO Howard Liang told the South China Morning Post.

The underwhelming debut performance casts another shadow over an anticipated biotech boom on the Hong Kong exchange. China’s first pre-profit biotech to go public — Ascletis — suffered a 15% plunge days after its stock went live. Six others have filed IPO pitches.

Some analysts have attributed the lackluster demand to poor market sentiments dragged down by trade war tensions, while others have interpreted it as collateral damage of recent vaccine scandals in China.

https://bit.ly/2AT5YyB