|
|
M Tue W Th F |
1 February, 2022 |
|
|
|
|
|
The last few days have made it completely clear that we're in for a painful retrenchment on the biotech side. And it's also clear — to me at least — that we're entering a new cycle on M&A and deals. Except that now we're in a buyers market. Stay tuned — this is just getting started. |
|
John Carroll |
Editor & Founder, Endpoints News
@JohnCendpts
|
|
|
|
|
Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images) |
|
by Nicole DeFeudis
|
—With the fate of Novartis’ generics unit up in the air, more potential buyers are reportedly lining up for what could be one of the largest M&A deals the industry has seen in the last year or so. Blackstone and the Carlyle Group are considering a joint offer for Sandoz that could value that unit at up to $25 billion, Bloomberg and the Financial Times reported on Tuesday. Someone with knowledge of the matter has confirmed to Endpoints News that Carlyle is in talks with Blackstone regarding a potential offer. When asked about the reports, a Novartis spokesperson simply said: “We don’t comment on market rumor and speculation.” The news comes about a month and a half after reports emerged from Germany that EQT and the billionaire Strüngmann brothers were in talks over a $21 billion bid. This wouldn’t be the Strüngmanns’ first rodeo, as they sold Hexal to Novartis in 2005. Novartis’ Vas Narasimhan confirmed back in December that he's seen some unspecified M&A interest, though no hard offers were on the table. In October, the chief executive flagged a plan to undertake a strategic review of Sandoz to see whether the generics group should stay inside Novartis, or be sold or spun off into an independent company. Generic drug prices have remained under intense pressure — and now, Narasimhan could follow in the footsteps of Merck, J&J and others and split off from the generics unit entirely. |
|
|
|
|
William Pao (L) and Hans Clevers |
|
by John Carroll
|
Pfizer has found its new chief of drug development, and they’ve dispatched a raiding party to Basel to pluck him off the executive committee at Roche. William Pao, who took over as head of pRED after John Reed exited to take the R&D chief post at Sanofi in 2018, is headed to the executive committee at Pfizer now, where he’ll report to Albert Bourla in New York. And he has a big remit that includes "inflammation and immunology, internal medicine, hospital, oncology and rare disease, as well as regulatory affairs in support of Pfizer’s R&D pipeline and portfolio of marketed therapies." Pao is replacing Rod MacKenzie, who recently opted to retire after a 35-year stint at the pharma giant. And he's coming in at a time Pfizer is doubling down on innovation for its future, with drug development in the center ring. Roche in the meantime has opted to bring in Hans Clevers for Pao’s job, making the switch from the board to top R&D exec on March 18 as Pao heads to the US for his new job. Clevers is a noted professor in molecular genetics at the University of Utrecht and will now step off the board in a move reminiscent of Tom Lynch's brief move from Bristol Myers Squibb's board to run R&D. He's now in charge of Fred Hutch. Roche and Pfizer maintain two of the largest R&D organizations on the planet. In 2020 they spent a combined $24 billion on drug research and development, with huge global organizations to back large pipelines. |
|
|
|
|
by Zachary Brennan
|
Beginning in March, Pfizer will become the 13th pharma company to restrict sales of its drugs through a federal program that offers steep discounts for low-income individuals. The 340B program has come under fire as, according to the pharma companies, it has ballooned in recent years to include numerous contract pharmacies working with certain qualified hospitals. The hospitals, meanwhile, have criticized the unilateral moves by the pharma industry and have lost millions in revenue from the changes. Like its fellow peers, Pfizer said in a letter to stakeholders last week that it's cutting back on its participation in the federal 340B program after reviewing examples, and evaluating the wider risk, of "duplicate discounts and diversion that occur through contract pharmacy transactions." Other companies like Novartis and Eli Lilly previously raised similar concerns, explaining how the 340B program had grown beyond what it was initially tasked to do and how it was lining the pockets of hospitals. HHS, meanwhile, has sought to crack down on these pharma companies, although mixed court decisions have complicated the situation. Pfizer's institution of its new "Defined Distribution system" will be for its JAK inhibitor Xeljanz and oral oncology drugs, as part of plans "to more effectively detect duplicate discounts and diversion that would otherwise go undetected." The company also makes clear that any 340B hospital-covered entity that "declines to provide the requested limited claims data" and "does not have an in-house pharmacy capable of dispensing 340B priced drugs to its patients," may designate a contract pharmacy location online via Pfizer's new 340B ESP platform. |
|
|
|
|
by John Carroll
|
Plagued by a woeful launch for its Alzheimer’s franchise, Biogen is betting $30 million on some reliable partners at Genentech to come up with a fast new franchise drug — outside of its CNS specialty. The therapy is mosunetuzumab, a "breakthrough" designate at the FDA which looks perfectly positioned for a shot at an accelerated approval. Working on their longtime collaboration on CD20, Biogen will chip in on some of last year’s R&D work and add a $30 million payment to step in to co-commercialize the drug. The drug is one of a lineup of CD20xCD3 T-cell engaging bispecifics in play for B cell non-Hodgkin’s lymphoma, which includes follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). Genentech has already flagged for a quick filing on FL as a third-line treatment, relying on a recent presentation of the stellar data it’s gathered so far to set the stage. Biogen picks up joint decision-making rights on development and commercialization, with a hefty take in the low to mid 30% range on profits (or losses) in the US, along with dibs on low single-digit royalties on sales outside the United States. You can bet at this stage of the game, they’re calculating some profits. Roche certainly is. And analysts have tacked a $1 billion blockbuster consensus estimate for peak sales. Analysts have been closely tracking this drug, and how it should play as Roche builds up its hematology portfolio with mosunetuzumab as well as a very aggressive glofitamab as well as cevostamab following up behind Polivy. |
|
|
|
|
Hip-Hop/R&B musician and actress Mary J. Blige stars in Hologic\'s first-ever Super Bowl ad (via Hologic) |
|
by Beth Snyder Bulik
|
If Mary J. Blige can make time for health checkups, so can you. That’s the message behind medical device and diagnostics company Hologic's soon-to-be-debuted Super Bowl and Winter Olympic ad campaign. The Grammy-winning R&B/hip-hop musician and actress travels from set to studio to gym to boardroom in the upcoming TV ads that will debut during the high-profile – and pricey – ad showcase Super Bowl on Feb. 13. The upshot? Even busy Blige can make time for annual women’s healthcare visits. TV time for the big game – known in the ad world as the biggest US mainstream audience of the year – is going for as much as $6.5 million for 30 seconds this year. The first-ever Super Bowl ad for Hologic is also the company's first direct-to-consumer TV ad. Why the Super Bowl? After all, the broadcast is more typically stacked with beer, snack food, car and movie trailer advertising. "There's a difference between serious and important," Jane Mazur, Hologic VP of corporate communications, said. "Your health is obviously no laughing matter like a chip commercial or some insurance ad, but I do think the stage allows us to share a message that will resonate with anybody watching. You can't ask for a better moment in time." Hologic, which is the leading maker of mammography machines along with its women’s health products and diagnostics, wants to remind women that no matter the many responsibilities they deal with daily, finding time to prioritize health is just as important. As Mazur notes, not only did the pandemic disrupt preventative healthcare visits, but women in general do tend to put others ahead of themselves. |
|
|
|
|
by Zachary Brennan
|
As the Belgian pharma UCB recently inked a $1.9 billion deal to buy out Zogenix and its top drug for epilepsy, the company's former controversial opioid has now been pulled from the market, according to a Federal Register filing by the FDA on Tuesday. Hydrocodone-based Zohydro ER — which initially won FDA approval in 2013 despite not having abuse-deterrent properties and despite an 11-2 adcomm vote against approval — is now one of 29 new drug applications from multiple sponsors that have decided to pull their drugs from the market for various reasons, according to the filing. The filing to pull Zohydro was made by Zogenix's Georgia-based contract manufacturer Recro Gainesville. In 2015, Zogenix sold Zohydro ER to Pernix Therapeutics for $100 million plus regulatory and sales milestones up to $284 million. In 2019, Pernix was sold to New Jersey-based Currax Pharmaceuticals, which is who most recently distributed the drug. Back in 2014, Zohydro made headlines as Massachusetts banned the prescription, ordering, dispensing, and administration of the new opioid, but then had that ban overturned in court, with Zogenix arguing that the ban was preempted by federal law. “If the Commonwealth were able to countermand the FDA’s determinations and substitute its own requirements, it would undermine the FDA’s ability to make drugs available to promote and protect the public health," the federal court said in its decision. The FDA also came under fire for the approval and went to great lengths to try to defend the opioid, as well as to correct misinformation around the drug's strength, which is something the agency rarely does. |
|
|
|
|
by Josh Sullivan
|
After more than 500,00 people have died in connection to the family’s drug, and the Hulu miniseries Dopesick cast a broader light on the family’s involvement in the opioid crisis that has ripped through America, members of the Sackler family are closing in on an agreement to add to the $4 billion offer to solve litigation surrounding the opioid crisis caused, in part, by the pain relief drug OxyContin. A federal judge overturned a $4.5 billion settlement in December that shielded members of the family from future litigation from the scandal that has led Purdue Pharma into a bankruptcy reorganization. The deal would have dissolved Purdue, and released the company’s owners — the Sacklers — from liability in the deal. But judge Colleen McMahon, from the US District Court’s southern district of New York, said it should not go forward. The deal would have called for the Sacklers to fork over ownership of Purdue while individuals get off scot-free. Judge Robert Drain originally approved the plan in September, lamenting that much of the Sackler’s money had been kept in off-shore accounts, and calling the result “bitter,” as furthering the delay would have taken more time, and kept even more money from the states which have sued. A mediator, former bankruptcy judge Shelley Chapman, said that any further contribution from the Sacklers would be used only for opioid abatement. Negotiations ran from Jan. 25-26, and were more than 12 hours long each day, Reuters reported. |
|
|
|
|
by Nicole DeFeudis
|
As biotech stocks continue to tumble, a Boston-based company struggling to gain a foothold in the noisy weight loss market is the latest to bring out the budget axe. Gelesis has reportedly laid off around 140 contractors hired to promote its weight loss capsule Plenity, effective today according to the Boston Globe, which broke the news. The move comes on the heels of a disappointing SPAC merger, which brought in significantly less cash than the PureTech spinout was initially counting on. Gelesis snapped up an approval for Plenity — which is technically considered a medical device — back in 2019. Taken twice a day before lunch and dinner, the $98-per-month treatment is designed to expand in the stomach, making adults feel fuller with smaller portions of food. In July, Gelesis struck a deal to merge with Capstar Special Purpose Acquisition Corp, lining up a potential $376 million in proceeds. The company called in Syneos to build a team of contractors to promote the treatment, which requires a prescription, according to the Globe. Until recently, marketing efforts relied heavily on social media efforts, as Gelesis said it was building out a commercial-scale manufacturing facility. But when its public debut finally came around last month, Gelesis only reaped about $105 million in proceeds as more than 98% of investors bailed out, the Globe reported. After the merger, the company informed about 140 members of the promotional team they were being laid off. Gelesis is the third PureTech entity to go public after Karuna Therapeutics hit Nasdaq with a traditional IPO in 2019 and Vor Biopharma followed suit in early 2021. |
|
|
|
|
by Josh Sullivan
|
Following a monster 2021, in which CDMO Recipharm expanded its footprint across the world in places with a smaller manufacturing presence, it's expanding its footprint in a European country where it's already established: Portugal. The Swedish company announced its acquisition of GenIbet, a CDMO based in Oeiras, Portugal that was spun out of an iBET - Instituto de Biologia Experimental e Tecnológica - lab in 2016. The move will help Recipharm build out its biologics capabilities, and benefit from GenIbet’s experience with viral vectors and vaccines, as it looks to focus on the manufacturing of novel advanced therapy medicines. It will inherit GenIbet’s 70 employees at the nearby site just 11 km from Recipharm's facility in Lisbon. GenIbet made headlines last year when it revealed that it worked with Moderna to produce some of the earliest batches of mRNA for Moderna between 2015 and 2019. It was the only manufacturer in Portugal to harness those bragging rights and received a thank you from Moderna CEO Stéphane Bancel. “Moderna is very thankful to GenIbet Biopharmaceuticals,” he said in 2020. “They partnered together to take the very first Moderna mRNA vaccine in the clinic at the end of 2015. The GenIbet team provided Moderna with a high quality GMP product and we are thankful for its work.” Though the work wasn’t directly related to Covid-19 research, the study of the mRNA technology helped Moderna learn more about the technology that was eventually used in the vaccines. |
|
|
|
|
by Amber Tong
|
Days before it would nail down the FDA’s approval for its epilepsy drug Fintepla, Zogenix received one of the first inquiries from a pharma company about pursuing a potential partnership to market the drug in the EU and other geographies outside the US. But it wasn’t until the OK came through, in late June, that eventual buyer UCB made initial contact, according to an SEC filing detailing the background leading up to the deal. The inside look documents a three-way negotiation that lasted half a year before UCB, the Belgian pharma, emerged victorious with a $1.9 billion offer. The narrative features three key players: Party A, a pharma company that first expressed its interest on June 4; UCB, which made contact on July 19; and Party B, a global pharma player that touched base on Aug. 3 about a potential US deal. A week after that initial introduction, Party B became the first to bring up a potential acquisition, as execs called Zogenix CEO Stephen Farr to discuss either partnering in the US or buying out the company — to which Farr replied he was not interested. Things took a turn in September, following a board meeting around Zogenix’s financial needs and the state of the broader biotech market. When UCB’s EVP of neurology and head of Europe/international markets, Charl van Zyl, communicated its first non-binding offer to acquire the biotech — later confirmed in an offer at $20.50 per share — it was told that the price was “materially inadequate.” |
|
|
|
John Carroll
|
Editor & Founder
|
|
Arsalan Arif
|
Publisher & Founder
|
|
|
|
Shehla Shakoor
|
Managing Director
|
|
Igor Yavych
|
Chief Technical Officer
|
|
|
Mike Peck
|
Chief Revenue Officer
|
|
Valentin Manov
|
Creative Director
|
|
|
|
Kyle Blankenship
|
Managing Editor
|
|
|
|
Beth Snyder Bulik
|
Senior Editor
|
|
Zachary Brennan
|
Senior Editor
|
|
|
|
|
|
Josh Sullivan
|
Associate Editor
|
|
|
|
Kathy Wong
|
Assistant Editor
|
|
Melissa Nazzaro
|
Sales Director
|
|
|
Cassidy Murphy
|
Sales Associate
|
|
Jaime Bruder
|
Sr. Operations Manager
|
|
|
|
Kara Thibault
|
Operations Manager
|
|
Jordan Collins
|
Operations
|
|
|
Lirra Selibio
|
Subscriptions
|
|
Dawn Cleveland
|
Controller
|
|
|
|
|
Amanda Florez
|
Executive Assistant
|
|
|
Alex Lefterov |
Graphic Designer |
|
DeAna Catoni
|
Operations Coordinator
|
|
|
|
Kari Abitbol
|
Director, Studio
|
|
Julie Notario
|
Sales Director
|
|
|
|
Paul Schloesser
|
Associate Editor
|
|
|
|
Derek Graf
|
Copy/Visuals Editor
|
|
Andrii Tomchyshyn
|
Lead Developer
|
|
|
Clara Bui
|
Virtual Producer
|
|
|
|
|
|
|
Worldwide made. Thanks for reading.
|
|
|
|