Pro­to­cols: My­lan’s EpiPen strat­e­gy stirs fresh out­rage over price goug­ing; a flail­ing Wood­ford halts big bonus­es

For­get Mar­tin Shkre­li. The bad-guy role in the phar­ma world has now been hand­ed to My­lan, which has been hit with a tsuna­mi of me­dia cov­er­age about its price goug­ing habits in­volv­ing the EpiPen. The decades old in­jec­tion de­vice need­ed to sur­vive life-threat­en­ing al­ler­gic episodes was sold for $100 back in 2007, when My­lan bought it, and now goes for $608.61 af­ter a se­ries of steep price hikes. The price has risen so high, some par­ents can’t af­ford it any longer, and an on­line mob has as­sem­bled to dig­i­tal­ly pil­lo­ry My­lan. My­lan, of course, is fol­low­ing a tried and true prac­tice in phar­ma­land, steadi­ly hik­ing whole­sale prices of old tech­nol­o­gy. Eli Lil­ly, among many oth­ers, has been do­ing ex­act­ly the same thing for quite some time. And with politi­cians fo­cused on a pres­i­den­tial elec­tion year, fears con­tin­ue to rise in the in­dus­try that elect­ed of­fi­cials may at­tempt to stop the prac­tice. There are no laws pre­vent­ing price goug­ing in bio­phar­ma, but some politi­cians are look­ing for the FTC to in­ves­ti­gate mo­nop­oly pric­ing. Mar­tin Shkre­li got this con­tro­ver­sy start­ed with his de­ci­sion to hike the price of an an­cient ther­a­py by  more than 5000%. Soon af­ter, Valeant be­come the poster child for price ma­nip­u­la­tion. And it has be­come a po­tent con­sumer is­sue that may well af­fect every­one in drug de­vel­op­ment, even­tu­al­ly.

The staff at Ox­ford-based Wood­ford In­vest­ment Man­age­ment has had a bad year. And now they can go with­out the big an­nu­al bonus­es that funds are known to pay. Neil Wood­ford says that there’s no cor­re­la­tion be­tween bonus­es and suc­cess. And af­ter ex­pe­ri­enc­ing set­backs at sev­er­al of his top biotech in­vest­ments, he has the num­bers to back it up.

In­dia’s Vy­ome Bio­sciences has raised $14 mil­lion for its R&D work on skin dis­eases. Per­cep­tive Ad­vi­sors and Ro­mu­lus Cap­i­tal led the round, with con­tri­bu­tions from Kalaari Cap­i­tal, Sabre Part­ners and Aarin Cap­i­tal.

Af­ter sell­ing its IP to No­vo Nordisk, Dublin-based Mer­rion is liq­ui­dat­ing its re­main­ing as­sets.


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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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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Lian­Bio an­nounces terms for IPO next week; NIH and White House of­fi­cials dis­cuss hy­po­thet­i­cal bio-med re­search agency

LianBio, a biotech that has operations in both the US and China, announced the terms yesterday for its initial public offering.

The biotech plans to raise $325 million by offering 20.3 million shares priced between $15 and $17.

At the midpoint of the proposed range, LianBio could command a fully diluted market value of $1.8 billion, based on a number of expected outstanding shares.

The two year old biotech has focused on in-licensing and commercialization of therapeutics in China, Hong Kong, Taiwan, Macau and other Asian markets. The company currently has nine programs across five therapeutic areas, including oncology, cardiovascular, and inflammatory diseases.

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.

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.

Boost­er bo­nan­za: FDA en­dors­es 'mix-and-match' scheme, and Mod­er­na and J&J too

The FDA late Wednesday signed off on authorizing the use of heterologous — or what FDA calls a “mix and match” of a primary vaccine series and different booster doses — for all currently available Covid-19 vaccines, in addition to separately authorizing Moderna and J&J boosters.

On the mix-and-match approach, which FDA officials insisted isn’t too confusing in a press conference, the agency offered the example of an 18-year-old who received the J&J shot at least two months ago and may now receive a single booster of the J&J, a half dose of the Moderna, or the Pfizer-BioNTech booster.

David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.