Bio­gen to pay $1.25B to de-risk a Tec­fidera patent bat­tle, and For­ward Phar­ma’s shares rock­et up

Michel Vounatsos, Bio­gen

Bio­gen will pay For­ward Phar­ma $1.25 bil­lion in cash to help sat­is­fy the Dan­ish biotech’s claims that its flag­ship mul­ti­ple scle­ro­sis drug Tec­fidera in­ter­fered with its patents.

The pricey set­tle­ment comes in ex­change for a li­cense agree­ment on the tech­nol­o­gy used in the 480 mg dai­ly dose, which was at the cen­ter of the IP dis­pute. And if For­ward wins their in­ter­fer­ence case be­fore the Patent Tri­al and Ap­peal Board, Bio­gen has agreed to pay a roy­al­ty on sales.

For­ward Phar­ma’s shares $FWP sky­rock­et­ed 63% on the news.

If For­ward goes ahead and wins the dis­pute, Bio­gen will pay 1% roy­al­ties if it winds up shar­ing the mar­ket with a co-ex­clu­sive li­cense. That fig­ure ris­es to 10% on an ex­clu­sive li­cense from 2021 to 2028. And the rev­enue stream for ex­clu­sive sta­tus jumps to 20% on Jan­u­ary 1, 2029.

Bri­an Abra­hams at Jef­feries at­tend­ed the hear­ing at the end of No­vem­ber, and came away think­ing that Bio­gen had been ex­posed to the tough­est line of ques­tion­ing. Kyle Bass’s group has been ham­mer­ing away at the Tec­fidera patents as well. And Bio­gen ev­i­dent­ly was per­suad­ed that it was bet­ter to set­tle for a sig­nif­i­cant sum now rather than take its chances with a ma­jor set­back.

From the an­a­lysts’ per­spec­tive, Bio­gen’s deal has some re­al up­side for the Big Biotech, pro­tect­ing it from Bass’s as­sault and any oth­er patent chal­lenge that comes along.

For Bio­gen, the pay­out comes as Tec­fidera sales have be­gun to wane, putting ex­treme pres­sure on the com­pa­ny to do some­thing dra­mat­ic to en­hance its pipeline. It al­so comes af­ter a num­ber of high-pro­file patent cas­es, in­clud­ing the big loss Re­gen­eron/Sanofi were ex­posed to in their dis­pute with Am­gen over the PC­SK9 fran­chise.

“We are very pleased to have reached this set­tle­ment with For­ward Phar­ma. We be­lieve this agree­ment will clar­i­fy and strength­en our in­tel­lec­tu­al prop­er­ty for TEC­FIDERA, the lead­ing oral ther­a­py for mul­ti­ple scle­ro­sis,” said Michel Vounatsos, the new CEO of Bio­gen.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

Some can­cer pa­tients now have to find oth­er op­tions as Bris­tol My­er­s' Abrax­ane falls in­to short­age from man­u­fac­tur­ing woes

When Beth Hogan, a metastatic pancreatic cancer patient, showed up for her infusion at Yale’s Smilow Cancer Hospital in New Haven, CT on Oct. 11, she said she was informed that day that she would not be receiving Bristol Myers Squibb’s Abraxane, part of her combo treatment, because of a shortage.

“I was told we don’t know when you can have it,” she told Endpoints News via email, adding that she doesn’t expect to receive any Abraxane this coming Monday at her treatment appointment either, and she doesn’t know when things will change.

Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

Up­dat­ed: Bio­gen sells just $300K worth of Aduhelm in Q3, as ques­tions on long-term vi­a­bil­i­ty re­main

Barely anyone is accessing Biogen’s controversial Alzheimer’s treatment, with the company reporting just $0.3 million in Aduhelm sales in the third quarter. Although investors will be looking to the longer term, when CMS may decide to cover the drug and open the floodgates for more reimbursement, use of the drug is currently stalled.

Since June, when the FDA first signed off on the drug under its accelerated pathway, Biogen said Wednesday that it’s sold a total of $2 million worth of Aduhelm. That’s a far cry from the peak Wall Street sales estimate of about $9 billion in annual sales, and even a ways away from the sell-side consensus of about $17 million in Q3 sales.

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Eli Lil­ly or­dered to pay roy­al­ties on block­buster di­a­betes drugs, though ex­act dam­ages are un­clear

A federal court found Eli Lilly in breach of a royalty agreement with an Arizona company, likely sending the case — which deals with Lilly’s blockbuster diabetes drugs — to a trial.

The Arizona District Court ordered Lilly to pay the royalties to Tucson, AZ-based Research Corporation Technologies, per an opinion delivered Tuesday, stemming from a 1990 agreement involving materials used in manufacturing Lilly’s insulin products. Lilly had agreed to pay a 2% royalty on worldwide sales, and the exact amount of damages will be determined in a trial, Judge Scott Rash wrote.

Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.