Joe Wiley, Amryt CEO

A biotech with a yen for pricey rare dis­ease drugs — and bar­gain base­ment shop­ping — adopts an­oth­er or­phan in lat­est M&A pact

Af­ter mak­ing it through a long, painful haul to get past a CRL and on to an FDA ap­proval last sum­mer, lit­tle Chi­as­ma has found a buy­er.

Am­ryt $AMYT, a com­pa­ny known for its ap­petite for ac­quir­ing ex­pen­sive drugs for rare dis­eases at bar­gain prices, snagged Chi­as­ma and its acromegaly drug My­capssa (oc­treotide) cap­sules in an all-stock deal — with an ex­change of 0.396 shares of Am­ryt for every share of Chi­as­ma.

The Need­ham, MA-based Chi­as­ma $CHMA launched My­capssa last Sep­tem­ber, but record­ed less than $2 mil­lion in sales for Q1. Now Am­ryt says it can carve out $50 mil­lion in an­nu­al “syn­er­gies” with the deal as it us­es its in-house group to mar­ket the drug and look for an ex­pand­ed la­bel. That may hit the staff of 84 em­ploy­ees at Chi­as­ma.

Chi­as­ma start­ed the day with a mar­ket cap of $164 mil­lion, with shares shoot­ing up 44% on news of the buy­out.

Chi­as­ma had crashed close to 5 years ago when the FDA re­ject­ed My­capssa and sent the com­pa­ny back to the draw­ing board af­ter ques­tion­ing the de­sign of their piv­otal study. Their drug is an oral ver­sion of so­mato­statin ana­logues used to treat an over­pro­duc­tion of growth hor­mones that leads to or­gan growth.

Af­ter they fi­nal­ly won their OK, the com­pa­ny rolled it out at a cost of $5,152 for a 28-day course of ther­a­py at the start­ing dose.

Am­ryt — with a mar­ket cap of $351 mil­lion — picked up some ex­tra at­ten­tion last fall when the com­pa­ny an­nounced pos­i­tive top-line re­sults for its drug Fil­su­vez for epi­der­mol­y­sis bul­losa, though it sparked plen­ty of ques­tions about a fail­ure on the sec­ondary side. The biotech is per­haps best known for their ac­qui­si­tion of Aege­ri­on, which net­ted two of the world’s most ex­pen­sive ther­a­pies: Myalept and Jux­tapid. They fol­lowed that deal by swift­ly up­ping the price by 9.99%.

The buy­er is now paint­ing in some block­buster num­bers around its new drug, though it’s vir­tu­al­ly start­ing from scratch on mar­ket­ing.

Am­ryt CEO Joe Wi­ley not­ed:

We see sig­nif­i­cant rev­enue growth op­por­tu­ni­ties for My­capssa in acromegaly and are al­so very ex­cit­ed to fur­ther de­vel­op the po­ten­tial for My­capssa in pa­tients with car­ci­noid symp­toms stem­ming from NET where we be­lieve the com­mer­cial op­por­tu­ni­ty is sig­nif­i­cant.

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.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Scott Struthers, Crinetics CEO

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

Largely known for its nonpeptide small molecule research, Crinetics has been keeping its radiopharma work comparatively under wraps. But that changed Monday afternoon as the California biotech spun out a new company focused solely on the burgeoning field.

Crinetics launched Radionetics after the closing bell Monday, the company announced, seeding the new entity with $30 million raised from 5AM Ventures and Frazier Healthcare Partners. Radionetics will start with its own radiopharma-centric platform and a pipeline of 10 programs aimed at solid tumors.

Jeffrey Nau, Oyster Point Pharma CEO

FDA OKs an in­haled ver­sion of smok­ing ces­sa­tion drug Chan­tix — for a com­mon eye dis­ease

Oyster Point Pharma now has its first FDA-approved product — Tyrvaya. And the biotech has taken a unique route to get there by using an old drug with a storied past.

The New Jersey biotech announced this morning that the FDA has approved their nasal spray product for dry eye disease on Friday — the first nasal spray to be approved for the disease. The product’s active ingredient is 0.03 mg of varenicline, also known as smoking cessation aid Chantix.