Alnylam Clocks 76% Increase In Q4 Product Sales, Expects FY22 Product Sales Of Up To $1B

 Alnylam Pharmaceuticals Inc's 

ALNY+2.36%+ Free Alerts

 Q4 product revenues increased 76% Y/Y to $198.5 million, primarily due to the continued global expansion of Onpattro and Givlaari, and sales from a third commercial product, Oxlumo.

• Collaborations sales increased 18%, primarily due to increased revenue from collaboration agreements with Regeneron Pharmaceuticals Inc 
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   and Novartis AG 
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  .
• Total sales increased to $258.5 million from $163.5 million, beating the consensus of $$233.62 million.
• The Company posted an adjusted EPS loss of $(1.69), missing the consensus of $(1.54) compared to the $(1.60) a year ago.
• Onpattro (patisiran) achieved sales of $139 million, +53.4% Y/Y, and attained over 2,050 patients worldwide on commercial Onpattro treatment as of December 31, 2021.
• Givlaari (givosiran) clocked Q4 sales of $40.69 million, +83.7%. The Company attained over 350 patients worldwide on commercial Givlaari treatment.
• Oxlumo (lumasiran) sales reached $19.2 million. Attained over 140 patients worldwide on commercial Oxlumo treatment.
• Guidance: Alnylam expects FY22 product sales of $900 million – $1 billion, with collaborations & royalties sales of $175 million – $225 million.

https://www.benzinga.com/general/biotech/22/02/25542781/alnylam-clocks-76-increase-in-q4-product-sales-expects-fy22-product-sales-of-up-to-1b

Emergent Stroke Care Within Reach for Nearly All in U.S.

Nearly all Americans live within an hour of emergency care for acute stroke, even if only by telestroke services, a study found.

Fully 96% of the U.S. population had access to an emergency department with any acute stroke capabilities within 60 minutes, reported Kori S. Zachrison, MD, MSc, of Massachusetts General Hospital in Boston, during the American Stroke Association's International Stroke Conference, held virtually and in person in New Orleans.

That represents an advance from 2011, when nearly 20% of the population didn't have timely access to a center where they could get thrombolytics, Zachrison and colleagues noted in a paper simultaneously published in JAMA Network Open.

"This increase likely reflects the extensive and ongoing work to improve stroke systems of care, including greater stroke center accreditation and expansion of telestroke capacity," they wrote.

While a major advancement, the findings suggest that the infrastructure part of advancing rapid stroke treatment might have just about peaked, said Cheryl Bushnell, MD, of the Comprehensive Stroke Center at Wake Forest Baptist Health in Winston-Salem, North Carolina, who is a spokesperson for the American Stroke Association.

However, "I think we might be struggling and maybe even going backward in having enough stroke experts for either the televideo or telestroke consults or working in the emergency department in person," she noted in an interview with MedPage Today monitored by her institution's media relations. "Having the processes in place is great, having the people is the challenge right now."

Other things that are outside of the hospitals' control, like getting people to immediately recognize stroke and seek medical care, and how long it actually takes for transport to the emergency department, are still a problem as well, she added.

Still, the analysis by Zachrison and colleagues turned up more than 13 million people (4% of the total U.S. population) who even in the best of circumstances wouldn't be able to reach emergency services with any acute stroke capability and some 5 million without 60-minute access to any emergency department at all.

"Although the smaller, critical access hospitals serving patients in rural areas are the most likely to benefit from telestroke services, they are currently the least likely to have them," Zachrison's group noted. "Addressing this care gap and other disparities in access will be critical to improving equitable access to acute stroke care for all Americans."

Another recent study documented disparities in driving distance for stroke care that particularly affect rural communities with a high proportion of minority residents.

The current study collated data from the 2019 National Emergency Department Inventory to identify all open emergency departments, which self-reported telestroke capacity and whether each was part of a hospital stroke center (including hospitals that can provide acute care even if patients require subsequent transfer). Calculation of timely access used 2020 U.S. Census data, looking for prehospital transport time of 60 minutes or less based on 2019 National Emergency Medical Services Information System data, considering EMS dispatch, response, scene times, and driving times.

Of the 5,587 emergency departments open in 2019, 46% were part of stroke centers and 45% had telestroke services. Of the 3,024 emergency departments not in a stroke center, 36% said they had telestroke capacity.

A comprehensive or thrombectomy-capable stroke center was within 60 minutes for 64% of the U.S. population.

Not surprisingly, the highest access to timely stroke care overall was in the mid-Atlantic region, with 99% of its population within 60 minutes of a telestroke-capable emergency department or a stroke center, and lowest in the Mountain West, at 91%.

A limitation to the study was the self-reporting of telestroke capabilities, which Zachrison's group did not confirm.

https://www.medpagetoday.com/meetingcoverage/isc/97100

Eisai bites back against restricted coverage plan for Aduhelm

 Japanese drugmaker Eisai has published comments filed with the US Centers for Medicare & Medicaid Services over its restrictive coverage proposal for beleaguered Alzheimer’s drug Aduhelm, saying it undermines well-established FDA processes.

The letter to CMS’ director of coverage and analysis Tamara Syrek Jensen said the decision to impose a coverage with evidence development (CED) on Biogen-partnered Aduhelm (aducanumab) – effectively limiting use of the drug to approved clinical trials – “limit, delay and deny people living with  [Alzheimer’s] access to FDA-approved medications now and in the future.”

It also claims that the use of a CED duplicates FDA processes in granting accelerated approval to new medicines “without the necessary statutory authority nor the scientific expertise to do so”, is discriminatory to patients, and calls into question the FDA’s role in determining their safety and efficacy.

If finalised, says the letter, the use of a CED could also set a precedent for other diseases and have a “chilling effect” on research throughout all of drug development, beyond the anti-amyloid class represented by Aduhelm and other late-stage drugs from the likes of Eli Lilly and Roche as well as Eisai and Biogen’s follow-up candidate lecanemab.

Eisai maintains that CEDs should not apply to investigational therapies at all, as deciding before FDA approval to limit patients access runs counter to applicable law.

“In our opinion, CMS’ approach is not based in science,” says the latter, which is signed by Lynn Kramer, chief clinical officer for Eisai’s neurology business group. “The agency is assuming that all drugs in the class are identical, which is incorrect.”

It goes on to say that CMS “is extrapolating from its assessment of failed clinical trial results from the first generation of these medications…to restrict patients’ access to not only an FDA-approved medication but all future drugs that operate by the same mechanism, without regard to FDA decisions on such products and the availability of much more relevant and growing evidence.”

A final decision by the CMS is expected by 12 April, and will pretty much set the seal on whether or not Eisai and Biogen can expect to make tangible revenues from Aduhelm in the coming years. CMS’ initial decision came despite Biogen slashing the cost of Aduhelm in half to $28,200 a year, acknowledging that it had made a mistake in its initial pricing level.

Biogen chief executive Michel Vounatsos issued a plea on a recent call with investors for Aduhelm supporters to mobilise behind the drug, and submit their own comments to the CMS to ask for a rethink.

To date there have been almost 13,0000 comments posted to the CMS on the decision, and a recent analysis by Bank of America analysts found that those backing the restrictions outweighed the other camp threefold.

https://pharmaphorum.com/news/eisai-bites-back-against-restricted-coverage-plan-for-aduhelm/