FDA allows emergency use of drug remdesivir for COVID 19

The US Food and Drug Administration on Friday authorized Remdesivir (a nucleoside ribonucleic acid (RNA) polymerase inhibitor) an experimental antiviral drug, for emergency use to treat Covid-19.

The authorization allows the intravenous drug to be distributed to doctors to administer to patients with severe disease.

Many health experts have had high hopes for the drug, which was initially developed by Gilead Sciences to treat Ebola. In past,it was also  used in experiments to treat the coronaviruses SARS and MERS. That early testing gave remdesivir a head start in the race for a treatment to Covid-19.

The NIH trial, called the Adaptive COVID-19 Treatment Trial, included 1,063 patients. The results showed that the median time to recover for patients who randomly received the placebo was 15 days while patients who received remdesivir had a median recovery time of 11 days. Remdesivir also lowered the mortality rate compared to the placebo group, from 11.6 percent to 8 percent.

These results, however, are preliminary. There are at least 19 studies on remdesivir around the world underway or in planning stages, some recruiting thousands of patients. It will be several months before they yield definitive answers, but they will, hopefully, bring the world closer to a working treatment.

Earlier  a randomized trial of the drug in China recently published in the Lancet  found that there was no statistical benefit to taking the drug. The study  was based on a true randomized controlled trial from Wuhan, China, with 237 patients. The study was also peer-reviewed by other scientists. Initially, the authors wanted to include up to 450 patients, but the lockdown imposed in the city meant that patients stopped arriving.

The FDA on 28^th March, 2020  had approved  emergency use authorization to a malaria drug, hydroxychloroquine, after President Donald Trump repeatedly promoted it as a possible treatment for COVID-19. 

Here is the link to the announcement.

US FDA announcement  

Bayer and Monsanto to Create a Global Leader in Agriculture

In the largest deal of 2016 (so far), after months of negotiations  with several  baby steps  agriculture giants Bayer and Monsanto announced  that  they are planning to merge. In an  all-cash   transaction    Bayer  striking the deal a $128  a share  valuing Monsanto at $66B.  including the debt.

Consolidation has been driven by a global  glut that has pushed down crop prices and hurt farm incomes, leading to reduced investment in agricultural inputs such as fertilisers and  Agrochemicals.   Several Mega & small mergers are right now underway/partially completed   like Dow Chemical and DuPont, ChemChina &   Syngenta, FMC & Cheminova  etc.

But the proposed merger  likely face an intense and lengthy regulatory process If the deal closes, it will create a company commanding more than a quarter of the combined world market for seeds and pesticides in the fast-consolidating farm supplies industry.

Both the   company executives claims the  businesses are complimentary & there is very little overlap between them.  However antitrust experts have said regulators  likely  demand the sale of some soybeans, cotton and canola seed assets.

The transaction includes a $2-billion break-up fee that Bayer will pay to Monsanto should it fail to get regulatory clearance. Bayer expects the deal to close by the end of 2017.

CRISIL rings Warning Bell for Indian Pharma Companies

A new Crisil report  made it clear how fast the Indian pharma sector needs to shift away from export-oriented manufacture of generics and the just process improvement  exercise, towards investing in R&D to develop new molecules and biosimilars  

Sellers of copycat drugs in developed markets may see exports fall by 10-12% in the next five years as fewer drugs go off-patent in these markets,  compare to  CAGR  of 19% seen in the last decade. CRISIL Research said. The deceleration likely to be much more post 2020.

Between 2011 and 2015, Indian companies accounted for an average of 37% of all abbreviated new drug application (ANDA) approvals—which enable a company to sell generic versions of innovator molecules —in the US market. This was about  similar   to 40%  share held by US companies, but way ahead of the next competing countries—Israel and Germany—which had 5% each.

Non availability of any   further off patent  block buster  and  fall  in growth rate  of   US generic market, the writing on the wall for Indian drug-makers is clear: They have to move up the value-chain, from making cheap copies of off-patent drugs to creating and owning intellectual property through new discovery and biosimilars. To be sure, they have increased R&D spending significantly over the years. Top 30 companies research spending was 6.5% of revenues in FY15, compared to 3.8%  a decade back. However, this pales in comparison with global majors, who spend close to 16%.

Moreover, the Crisil report points out, much of the Indian companies’ expenditure is  for launching generic therapies, changing product mix in generics, and process development. Besides, the atmosphere of doubt over drug quality—in the wake of the FDA’s crackdown—further dampens Indian generic-makers’ export-prospects. 

CRISIL Research analysis indicates that 14  Indian companies together have 39 products in various stages of clinical development. These companies have adopted various approaches—such as in-house development, joint development and out-licensing—to manage the risk-return trade-off.  However, no one has launched a new molecule in a regulated market such as the US.

Thus far,  it is  disappointing in NCE effort  but  39 product in the pipeline should be an encouraging sign for Indian pharma’s prospects. The key challenge will be to uphold drug-quality and pass the approval hurdles in well-regulated jurisdictions like the US.

Largest U.S. chemical companies to combine in megamerger. Could spark more deals!!

Two American  Chemical giants and possibly among the oldest,  DuPont and Dow Chemical  have agreed to combine in an all-stock merger valued at $130 billion  which  would be the 18th largest deal ever.

 

Dow Chemical Co. and Dupont Co. that are 118 and 213 years old, respectively, announced the blockbuster, tax free  deal that would take two years to complete.  Following the completion of the deal's in 2016, the  merged entity  would eventually    will  break up  into  3 separate, publicly-traded entities focusing on Agricultural products, Material sciences, and Specialty products.

The deal, the fifth-largest corporate merger of 2015, would certainly receive scrutiny from federal regulators, especially regarding the new companies  place in global agricultural production, including seeds, insecticides, and pesticides. Executives from both companies  however said the agrochemicals businesses have little overlap and any asset sales would likely be minor.

By revenue, the material sciences company – which makes products for the packaging, transportation, and infrastructure industries, to name a few – will be the largest. Its combined revenue in 2014 was around $51B on an adjusted basis. It will compete with the likes of corporate titans BASF, Honeywell, and 3M.

The specialty products company, with a combined revenue of $13B in 2014, would sell materials to the electronics and communications industries, among others.

The agriculture company, focusing on seeds and chemicals, would have a combined adjusted revenue of $19B overtaking BASF as the leader in agrochemicals. In the seed industry, DowDupont is pitted against behemoth Monsanto.

Dow shareholders would own 52 percent of the new company after preferred shares are converted, the companies said. The agreement includes a $1.9 billion termination fee under specified circumstances, such as rejection by shareholders.

The biggest impact will certainly be in the agriculture market, where the seeds and crop chemical industries are to undergo rapid consolidation

Prior to the merger, Dupont said in a statement it will slash $700 million in costs, with ten percent of its workforce "impacted" by the move, while Dow is expected to drop $300 million in costs.

As per Dealogic , this   merger would represent the 18th largest corporate deal of all-time. It would trail the 2015 deals made by Allergan and Pfizer, Anheuser-Busch InBev and SABMiller, BG Group and Royal Dutch Shell and Time Warner Cable and Charter Communications.

Dow and Dupont have a combined annual revenue of around $83 billion, with operating profit of about $15 billion.

Pfizer regains pole position by acquiring Allergan in a $160B deal.

Pfizer and Allergan are joining in the biggest buyout of the year, a $160 billion stock deal that will create the world's largest drugmaker. The deal is the latest and the largest to be aimed at helping an American company lower its taxes by reincorporating overseas, a practice known as a corporate inversion. The transaction would be structured as a so-called reverse merger, in which Allergan, the smaller of the two companies, would technically be the buyer.

Pfizer will keep its global operational headquarters in New York but   its legal domicile and principal executive offices in Ireland.  Legacy Pfizer expected to lead the combined company which will be called Pfizer Plc, which would have more than $63 billion in combined sales and a product portfolio that includes Viagra, Celebrex, Botox , Juvéderm and  about 110,000 employees worldwide.

Under the terms of the all-share deal, Pfizer would essentially pay $363.63 for each Allergan share .  Allergan shareholders would receive 11.3 shares of Pfizer for each share of Allergan they hold. Pfizer shareholders would receive one share in the combined company for each share they hold, but have the option to take up to $12 billion in cash for some or all of their shares instead.

Pfizer Inc. Chairman and CEO Ian Read will serve in the same roles with the combined company while Allergan Plc. leader Brent Saunders will become president and chief operating officer. The combined company’s board would consist of 15 directors, with Pfizer’s 11 current directors and 4 directors from Allergan.

After the transaction, Pfizer shareholders are expected to own about 56 percent of the combined company, with the remaining 44 percent owned by Allergan shareholders The combined entity expected to achieve more than $2 billion in annual cost savings over the first three years after the deal closes.

Pfizer said that it expected the combined company’s adjusted tax rate to be between 17 percent and 18 percent by the first year after the deal is finalized. Last year, Pfizer’s tax rate was about 26.5 percent, and it is expected to be about 25 percent this year. By comparison, Allergan reported a tax rate of just 4.8 percent for 2014 and is expected to have a tax rate this year of about 15 percent.

Pfizer, based in New York, has engaged in several large deals in recent years, buying Wyeth in a $68 billion  deal and  Hospira, a maker of generic treatments, for about $17 billion this year.

Allergan was created through several mergers since 2012 that included the drug makers Forest Laboratories, Actavis and Warner Chilcott.

The deal would enable Pfizer to surpass  Novartis AG  and regain the industry's top spot.