J&J’s Erleada has big shoes to fill, and a tough competitor

• Erleada, a prostate cancer drug from Johnson & Johnson, met the dual primary endpoints of a late-stage study testing it in patients with metastatic, castration-sensitive forms of the disease.
• A pre-planned interim analysis of the study, called TITAN, showed patients taking a combination of Erleada and androgen deprivation therapy (ADT) were living significantly longer without their cancer progressing and without dying than those who were getting ADT plus placebo.
• Investigators unblinded TITAN at the recommendation of an independent data monitoring committee to give participants in the placebo group the opportunity to join the experimental group. J&J said it will continue to evaluate overall survival and long-term safety, and plans to use the study data in an additional regulatory filing for Erleada.

J&J has for years held a dominant position in the prostate cancer therapy market with Zytiga (abiraterone acetate). In 2018 alone the drug raked in $3.5 billion for the big pharma, up nearly 40% from the year prior.

But that growth story won’t last much longer. Generic competition to Zytiga entered the U.S., which accounts for around half of drug’s worldwide sales, during the fourth quarter and has been snagging market share. Between the end of October and Jan. 25, Zytiga’s share of total stateside prescriptions slid from 56% to 31%, according to Iqvia data cited by investment bank Credit Suisse.

On an earnings call earlier this month, J&J noted that Zytiga sales declined 13% in the U.S. over the last quarter because of copycats, leading to a more modest year-over-year growth of 4%.

The situation isn’t entirely dire, however, as both analysts and J&J foresee Erleada (apalutamide) making up for some of Zytiga’s losses.

Though Erleada sales haven’t been astronomical since it came to market almost a year ago, the expectation is that it will be a key growth driver moving forward. The drug carries an approval for prostate cancer that hasn’t spread yet and continues to grow in spite of hormone therapy. With supportive data from TITAN, that label may soon expand.

Erleada’s path forward does face at least one challenge. Astellas and Pfizer’s Xtandi (enzalutamide) has since 2012 been approved for metastatic castration-resistant prostate cancer.

Last July, Xtandi received a label expansion of its own, making it the only oral medication available for both metastatic and non-metastatic prostate cancer. And in December it hit the primary endpoint of a Phase 3 study assessing the drug plus ADT in men with metastatic, hormone-sensitive prostate cancer — a market Pfizer claims sees 38,000 new patients annually.

Pfizer noted on its own January earnings call that six months after gaining an approval in the non-metastatic, castrate-resistant setting, Xtandi’s market share was quadruple that of Erleada’s. Newly minted CEO Albert Bourla said his company remains “focused on demonstrating the value of moving Xtandi into earlier treatment settings” and expects the drug to be “one of the pillars of our oncology portfolio for years to come.”

Xtandi has already demonstrated its value to Pfizer’s top line, as the big pharma recorded $699 million of revenue from the drug during 2018, up from $590 million in 2017.

J&J, meanwhile, contends it can grow market share for Erleada.

Joseph Wolk, the big pharma’s chief financial officer, said on the Jan. 22 earnings call that J&J will continue to mold its payer strategies to best convey the benefits of its products.

“We’ll continue to change our contracting with the landscape,” Wolk said. “We do have some outcomes-based pilots out there that are across a number of therapeutic areas. We think that’s a way that could potentially be a long-term solution.”

https://www.biopharmadive.com/news/johnson-erleada-titan-prostate-cancer-xtandi-zytiga/547313/

Payers balk at HHS proposal to end federal PBM rebates

The Trump administration’s announcement Thursday to end safe harbor protections for drug rebates to pharmacy benefit managers, Medicare Part D plans and Medicaid managed care organizations hit payer stocks Friday and has riled up the health insurance sector.

The policy change was expected. Sky-high drug prices have been a frequent target of President Donald Trump and his HHS Secretary, and PBMs have often received part of the blame. Those companies — now largely owned by the biggest payers like CVS and UnitedHealth — however, say they play an important role in the pharmaceutical supply chain and end up protecting consumers by saving them out-of-pocket costs.

In addition to the rebate changes, which would go into effect in January 2020 under the current proposal, the rule would create new legal safe harbors for fixed fee agreements between PBMs and drug manufacturers as well as discounts patients receive at the pharmacy counter.

Overall, it looks to be a blow for payers and PBMs. While the new rule would not apply directly to commercial plans, ripple effects are likely with such a major change.

Leerink analysts said that without the federal rebates, commercial rebates are likely to shrink, lest they look like an illegal bribe for better formulary changes. Smaller rebates are less effective, so if the proposal is implemented as is, “commercial rebates could very likely be eliminated,” analysts wrote in a note Friday.

Analysts at Jefferies, on the other hand, predicted the proposal’s impact on PBMs would be minimal, though the largest may lose some competitive advantage “as they will no longer be able to subsidize premium bids with rebate dollars.”

Express Scripts spokesman Brian Henry told Healthcare Dive that “rebates are just one funding mechanism in the basket of services” it offers, adding, “it is short-sighted to look at one component of our offering as having a disproportionate impact on our business model.”

The health insurance lobby nonetheless was quick to denounce the proposal. America’s Health Insurance Plans criticized the administration’s decision as “well-intentioned but misguided” and insisted that rebate savings go directly to consumers, saving them on premiums and cost-sharing.

“From the start, the focus on rebates has been a distraction from the real issue — the problem is the price,” said AHIP CEO Matt Eyles, in a statement. “Manufacturers have complete control over how drug prices are set. Already this year, more than three dozen drug makers have raised their prices on hundreds of medications.”

Eyles suggested HHS “go back to the drawing board and start over with this proposed rule.”

Pharmaceutical Care Management Association CEO JC Scott echoed that sentiment. Eliminating safe harbor protections “would increase drug costs and force Medicare beneficiaries to pay higher premiums and out-of-pocket expenses, unless there is a viable alternative for PBMs to negotiate on behalf of beneficiaries,” he said in a statement.

The move comes as the sector is rapidly evolving and major insurers have snapped up increasingly lucrative PBMs.

In a recent interview, Leerink analyst Ana Gupte told Healthcare Dive that putting medical and pharmaceutical benefits under one umbrella makes sense. “I think it’s a natural evolution of where this industry needs to go,” she said. “At the end of the day, the pharmacy benefit is integral to management of an insured member as a whole person.”

Cigna just closed its acquisition of Express Scripts, one of the country’s largest PBM, for $67 billion. During the company’s fourth quarter earnings call Friday, CEO David Cordani said he didn’t think the rule would have a “meaningful impact” on Cigna’s growth. He suggested the change could accelerate value-based programs with pharmaceutical companies.

As market and policy analysts pore over the 123-page proposed rule, much is still unclear about what the policy change would mean for PBMs and patients if finalized. For most Part D beneficiaries, the change would likely mean an increase in monthly premiums but a decrease in cost-sharing.

Tricia Neuman, senior vice president of the Kaiser Family Foundation, noted on Twitter the HHS analysis has 10-year budget impact estimates that range from $99.6 billion to $196.1 billion.

“That range in savings/spending estimates illustrate the complexity of financial arrangements between drug companies, pharmacy benefit managers, plans & beneficiaries, [and] the difficulty in predicting how each will respond if the current rebate system is upended to address problems,” she wrote.

HHS admits as much in its proposal: “It is difficult to predict the full extent of the transfers created by this proposed rule in the absence of information about strategic behavior changes by manufactures and Part D plan sponsors in response to this rule.”

A senior HHS officials said on a Thursday call with reporters, though, that because Part D “is such a premium-sensitive market,” the department expects plan sponsors “are going to negotiate more aggressively or make other changes such that they won’t have to increase premiums while still passing on lower costs at the pharmacy counter.”

https://www.biopharmadive.com/news/payers-balk-at-hhs-proposal-to-end-federal-pbm-rebates/547443/

ANI ends royalties to Teva for $16M

On January 30, 2019, ANI Pharmaceuticals, Inc. (the “Company”) entered into Amendment No. 4 to its Asset Purchase Agreement (the “Purchase Agreement Amendment”) with Teva Pharmaceuticals USA, Inc. (“Teva”). Under the terms of the Purchase Agreement Amendment, all royalty obligations of the Company owed to Teva with respect to products associated with ten ANDAs under the Asset Purchase Agreement shall cease effective as of December 31, 2018. In consideration for the termination of such future royalty obligations, the Company agreed to pay Teva a sum of $16,000,000.

https://www.marketscreener.com/ANI-PHARMACEUTICALS-INC-13658425/news/ANI-PHARMACEUTICALS-INC-Entry-into-a-Material-Definitive-Agreement-form-8-K-27951117/

Quotient Update on Performance, Disease Screening Field Trial

Quotient Limited (NASDAQ: QTNT) (Quotient or the Company), a commercial-stage diagnostics company, today provided internal performance evaluation data for its extended immunohematology (IH) microarray, and announced the commencement of the European field trial for its initial Serological Disease Screening (SDS) microarray. The Company also disclosed continued strong top line growth in its core liquid reagent business for the quarter and for the nine months ended December 31, 2018.

“I am very pleased to report the progress which we have been able to make. We are well positioned with an ISO certified MosaiQ manufacturing system, a CE marked MosaiQ instrument and the resources required to bring a commercializable MosaiQ testing menu to the transfusion diagnostics market. The Quotient team continues to operate well to achieve the targets which we set earlier this fiscal year.” said Franz Walt, Quotient’s Chief Executive Officer. Mr. Walt added “Our ongoing menu expansion plans are progressing well as evidenced by our first SDS microarray entering its field trial and the development data for our extended antigen panel.  When available, the extended antigen panel is designed to be a game changing innovation which will replace the initial IH menu that is planned for use in our European hypercare launch.”

https://globenewswire.com/news-release/2019/01/31/1708168/0/en/Quotient-Limited-Provides-an-Update-on-Extended-Immunohematology-Microarray-Performance-and-on-the-Commencement-of-the-Initial-Serological-Disease-Screening-Field-Trial-together-wi.html

Alkermes briefly falls, rebounds after announcing CRL for ALKS 5461

After the market close on February 1, Alkermes (ALKS) announced it received a Complete Response Letter, or CRL, from the FDA regarding its New Drug Application, or NDA, for ALKS 5461 for the adjunctive treatment of major depressive disorder, or MDD. FDA COMPLETE RESPONSE LETTER: The CRL stated that the FDA was unable to approve the ALKS 5461 NDA in its present form, and was requesting additional clinical data to provide substantial evidence of effectiveness of ALKS 5461 for the adjunctive treatment of MDD. Alkermes said it plans to meet with the FDA to discuss the contents of the CRL and potential next steps for ALKS 5461. This interaction with the FDA will inform whether there is a viable path forward for the ALKS 5461 program. The NDA submission for ALKS 5461 was based on results from a clinical efficacy and safety package with data from more than 30 clinical trials and more than 1,500 patients with MDD. ALKS 5461: ALKS 5461 is a proprietary, investigational, once-daily oral medicine that acts as an opioid system modulator and represents a novel mechanism of action for the adjunctive treatment of MDD, in patients with an inadequate response to standard antidepressant therapies. An estimated 16.2M people in the U.S. suffered from MDD in 2016, the majority of whom may not adequately respond to initial antidepressant therapy. CRL EXPECTED BY ALKERMES CEO: On January 8, Alkermes CEO Richard Pops, during a breakout session at the JPMorgan Healthcare Conference, said his company expected the FDA to issue a Complete Response Letter for its depression candidate ALKS 5461. PRICE ACTION: After initially falling 10% in reaction to the news after-hours, shares of Alkermes are little changed, down 0.2% to $33.08

https://thefly.com/landingPageNews.php?id=2857986

Evolus wins FDA approval for rival to Allergan’s Botox

Bloomgerg reports

https://thefly.com/landingPageNews.php?id=2857955

Alkermes receives CRL from FDA for ALKS 5461 New Drug Application

Alkermes announced that it received a Complete Response Letter from the U.S. Food and Drug Administration regarding its New Drug Application for ALKS 5461 for the adjunctive treatment of major depressive disorder. The CRL states that the FDA is unable to approve the ALKS 5461 NDA in its present form and is requesting additional clinical data to provide substantial evidence of effectiveness of ALKS 5461 for the adjunctive treatment of MDD. Alkermes plans to meet with the FDA to discuss the contents of the CRL and potential next steps for ALKS 5461. This interaction with the Agency will inform whether there is a viable path forward for the ALKS 5461 program. The NDA submission for ALKS 5461 was based on results from a clinical efficacy and safety package with data from more than 30 clinical trials and more than 1,500 patients with MDD. Throughout the clinical development program, ALKS 5461 demonstrated a consistent profile of antidepressant activity, safety and tolerability in the adjunctive treatment of MDD.

https://thefly.com/landingPageNews.php?id=2857968