AstraZeneca (AZN) gets US clearance of proposed acquisition of Alexion

 AstraZeneca’s (NYSE: AZN) proposed acquisition of Alexion Pharmaceuticals, Inc (NASDAQ: ALXN) has achieved an important step toward completion, having cleared US Federal Trade Commission review. This follows the conclusion of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

The announcement follows competition clearances in Canada, Brazil, Russia and other countries globally, with a full list available on astrazeneca.com. Additional global regulatory clearances are pending, including but not limited to the UK, EU and Japan.

Marc Dunoyer, Executive Director and Chief Financial Officer, said: “These clearances further advance us towards closing our acquisition of Alexion. We remain focused on the next chapter for AstraZeneca and Alexion, building on our combined expertise in immunology and precision medicines and our shared ambition to bring more innovative medicines to patients worldwide. We look forward to working closely with other global authorities as we progress toward this goal.”

The proposed acquisition, first announced in December 2020, would enhance the Company’s scientific presence in immunology by adding Alexion's innovative complement-technology platforms and strong pipeline. Rare diseases represent a high-growth disease area with rapid innovation and significant unmet medical need. The acquisition remains expected to close in Q3 2021, subject to receipt of additional global regulatory clearances and approval by shareholders of both companies with shareholder voting anticipated on 11 May 2021.

Subject to a successful completion of the acquisition, a dedicated business unit will be created, known as ‘Alexion, The AstraZeneca Rare Disease Unit’, headquartered in Boston, US. AstraZeneca will have an enhanced global footprint and broad coverage across primary, speciality and highly specialised care, and is expected to deliver double-digit revenue growth through 2025, double-digit core EPS accretion for the first three years as well as strong cash flow with an ambition to increase the dividend.

https://www.streetinsider.com/Litigation/AstraZeneca+%28AZN%29+receives+US+clearance+of+proposed+acquisition+of+Alexion+%28ALXN%29/18270576.html

Sinopharm to inject $4.6 billion vaccine assets into unit Tiantan Biological

 

Chinese state-owned Sinopharm plans to inject 30 billion yuan ($4.6 billion) in assets into unit Beijing Tiantan Biological Products Corp Ltd to quickly get its fast-growing vaccine business on the public market, two people told Reuters.

Sinopharm aims to begin the injection of six vaccine-focused biological products developers including makers of two COVID-19 vaccines into Shanghai-listed Tiantan in the coming weeks, said the people plus two other people with knowledge of the matter.

The plan comes as China races to develop more homegrown COVID-19 vaccines to challenge Western rivals. President Xi Jinping has pledged China's vaccines for the global public good.

It also comes as Beijing-based Sinopharm works to consolidate its biological units and boost the valuation of subsidiaries on public markets, said the people.

In January, Reuters reported that a Sinopharm-led consortium planned to take private China Traditional Chinese Medicine Holdings Co Ltd as the unit lagged a surge in valuation for many mainland China-listed peers.

Injecting six units into Tiantan could diversify fundraising channels, the people said. The six are either wholly owned or controlled by Sinopharm subsidiary China National Biotec Group Co (CNBG). CNBG also owns 50% of Tiantan, which focuses on blood products and had a market capitalisation of $7 billion Thursday.

Sinopharm - formally China National Pharmaceutical Group Co Ltd - Tiantan and CNBG did not respond to requests for to comment. The people declined to be identified due to confidentiality constraints.

HEALTHCARE DEALS

Asian healthcare deals recorded their strongest-ever growth rate last year at nearly 150% in terms of capital raised. The sector will likely dominate local capital markets again this year due to global COVID-19 vaccination drives, bankers said.

The six units Sinopharm aims to inject into Tiantan develop and manufacture a range of vaccines including two for COVID-19 as well as injectable cosmetic Botox, their websites showed.

One of the two COVID-19 vaccines, developed in Beijing, was the first approved for general public use in China in December, and has since gained emergency use approval in countries such as Iraq and Morocco. The unit can produce 1 billion doses annually.

The second, developed in Wuhan where capacity is 100 million does a year, gained Chinese public use approval in February.

In all, five domestically produced COVID-19 vaccines have been approved for use in China.

The other four Sinopharm units in the deal are based in the cities of Shanghai, Lanzhou, Changchun and Chengdu, Sinopharm's website showed.

Sinopharm has said it aims to expand annual COVID-19 vaccine capacity to 3 billion doses, without specifying a time frame.

https://www.marketscreener.com/quote/stock/BEIJING-TIANTAN-BIOLOGICA-6496889/news/Exclusive-Sinopharm-to-inject-4-6-billion-vaccine-assets-into-unit-Tiantan-Biological-sources-32983688/

Serum Institute appeals to Biden to lift embargo on raw material exports

 

The Serum Institute of India (SII), the world's biggest vaccine maker, on Friday urged U.S. President Joe Biden to lift an embargo on U.S. exports of raw materials that is hurting its production of COVID-19 shots.

"Respected @POTUS, if we are to truly unite in beating this virus, on behalf of the vaccine industry outside the U.S., I humbly request you to lift the embargo of raw material exports out of the U.S. so that vaccine production can ramp up," SII Chief Executive Adar Poonawalla said in a tweet.

SII is making the AstraZeneca shot for the world and will soon start producing the Novavax vaccine.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-nbsp-Indian-vaccine-maker-Serum-Institute-appeals-to-Biden-to-lift-embargo-on-raw-mate-32985265/

New data for Roche's OCREVUS (ocrelizumab) reinforce significant benefit on slowing MS

 -- 85% of treatment-naïve, early-stage relapsing-remitting multiple

      sclerosis (RRMS) patients achieved no evidence of disease activity (NEDA) 
      in open-label Phase IIIb ENSEMBLE study 
 
   -- OCREVUS significantly slowed loss of brain tissue within T2 MRI lesions 
      in primary progressive multiple sclerosis (PPMS) in post-hoc analysis of 
      Phase III ORATORIO study 
 
   -- OCREVUS-treated patients show highest adherence and persistence rates 
      compared with other disease-modifying therapies (DMTs) in two-year U.S. 
      claims analysis 

https://www.marketscreener.com/quote/stock/ROCHE-HOLDING-AG-9364975/news/Press-Release-nbsp-New-data-for-Roche-s-OCREVUS-ocrelizumab-reinforce-significant-benefit-on-slo-32983607/

Biomea prices IPO

Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a preclinical-stage biopharmaceutical company focused on the discovery, development and commercialization of irreversible small molecules to treat patients with genetically defined cancers, today announced the pricing of its initial public offering of 9,000,000 shares of its common stock at a public offering price of $17.00 per share. All of the shares of common stock are being offered by Biomea. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Biomea, are expected to be $153.0 million. Biomea’s common stock is expected to begin trading on The Nasdaq Global Select Market on April 16, 2021, under the ticker symbol “BMEA.” The offering is expected to close on April 20, 2021, subject to satisfaction of customary closing conditions. In addition, Biomea has granted the underwriters a 30-day option to purchase up to an additional 1,350,000 shares of common stock at the initial public offering price, less the underwriting discounts and commissions.

J.P. Morgan Securities LLC, Jefferies LLC and Piper Sandler & Co. are acting as joint book-running managers for the offering.

https://www.globenewswire.com/news-release/2021/04/16/2211351/0/en/Biomea-Announces-Pricing-of-Initial-Public-Offering.html

Lilly requests revoking emergency use for bamlanivimab alone in covid

 - Final step in Lilly's planned transition to provide only bamlanivimab and etesevimab together in the U.S.

- Bamlanivimab and etesevimab together now fully available across the U.S.

- Lilly, in collaboration with Amgen, expects to manufacture sufficient supply for complete global transition by June 2021

https://www.prnewswire.com/news-releases/lilly-requests-revocation-of-emergency-use-authorization-for-bamlanivimab-alone-to-complete-transition-to-bamlanivimab-and-etesevimab-together-for-treatment-of-covid-19-in-the-us-301270317.html

Medtechs top pharma in cash to doctors for consulting, travel: Health Affairs

 

• Medical device companies spent more money in non-research payments to physicians between 2014 and 2017 than drug companies, an analysis published Monday in the journal Health Affairs found. The payments covered services like royalties, consulting and speaking fees, as well as travel and food. Neurosurgery, orthopaedics and cardiology were among the surgical specialists most targeted by medtechs.
• Payments from medical device companies totaled $3.6 billion, or $904 million per year during the period. Meanwhile, payments from drug companies totaled $3.3 billion, or $821 million per year. While totals were somewhat similar, medtech payments went to about 135,000 fewer physicians than the pharmaceutical industry, making medical device payments to individual physicians larger.
• The majority of medtech payments came from 10 big companies, including Medtronic, Johnson & Johnson, Zimmer Biomet, Stryker and Abbott Laboratories.

Device companies' relationships with physicians are different than that of drug companies. Study authors note that physicians often play a larger role in the development of devices compared to the development of pharmaceutical drugs.

For example, medical device companies provide surgeons with training and education on specific products due to the complexity of implanting a device in a patient, which can lead to representatives from companies being in the operating room during procedures.

These differences may account for differences in the data, such as device companies spending more money on what's deemed education or royalties and licensing than drug companies.

However, study authors still cautioned that close relationships with industry could create bias if influence "comes from the firms with the deepest pockets instead of the firms with the best therapies."

The report used data from 2014 to 2017 from the Centers for Medicare and Medicaid Services Open Payments website, which tracks all industry payments made to U.S. physicians. Companies are required to report the payments.

One difference highlighted was the size of the total payments relative to the size of the medical device and pharmaceutical industries. While payments during the study period were similar in total, the medtech industry is smaller.

Between 2014-2017, about 1.7% of total medical device industry revenue was made up by physician payments, more than seven times the percentage of drug industry revenue made up by payments, according to the study.

Other differences included where payments went. Medical device companies' top three payment categories were royalty, licensing and investment, consulting fees, and speaking fees. Drug companies' top three categories were speaking fees, food and beverage, and consulting fees.

Nearly two-thirds of total physician payments came from 10 medical device companies, mainly the largest in the industry. These companies accounted for 17.6% of all FDA approved devices and "within the specialties that drive hospital spending on medical devices, these firms were even more dominant, accounting for 20% of cardiovascular devices, 19% of neurology devices, 34% of orthopedics devices, and 13% of surgery devices."

Device-approval data came from the FDA's public Global Unique Device Identification Database.

https://www.healthcaredive.com/news/medtechs-top-pharma-in-cash-to-doctors-for-consulting-travel-health-affai/597885/