Source: Streetwise Reports   05/05/2020

Commercial-stage biotechnology company Portola Pharmaceuticals Inc. (PTLA:NASDAQ), which focuses on blood-related disorders, and global biopharmaceuticals firm Alexion Pharmaceuticals Inc. (ALXN:NASDAQ) announced that they have entered into a definitive merger agreement for Portola to be acquired by Alexion.

The acquisition is said to provide a key addition to Alexion's diversified commercial portfolio. The report indicated that the merger agreement has already been unanimously approved each of the company's boards of directors.

The report explained that "Portola's commercialized medicine, Andexxa^® [coagulation factor Xa (recombinant), inactivated-zhzo], marketed as Ondexxya^® in Europe, is the first and only approved Factor Xa inhibitor reversal agent, and has demonstrated transformative clinical value by rapidly reversing the anticoagulant effects of Factor Xa inhibitors rivaroxaban and apixaban in severe and uncontrolled bleeding."

Portola's President and CEO Scott Garland commented, "In developing and launching Andexxa, Portola has established a strong foundation for changing the standard of care for patients receiving Factor Xa inhibitors that experience a major, life-threatening bleed. Andexxa rapidly reverses the pharmacologic effect of rivaroxaban and apixaban within two minutes, reducing anti-Factor Xa activity by 92 percent...Given their enhanced resources, global footprint and proven commercial expertise, we look forward to working with Alexion to maximize the value of Andexxa. With their commitment to commercial excellence, together, we will be able to drive stronger utilization of Andexxa, increase penetration and accelerate adoption in the critical care setting."

Ludwig Hantson, Ph.D., CEO of Alexion, remarked, "The acquisition of Portola represents an important next step in our strategy to diversify beyond C5. Andexxa is a strategic fit with our existing portfolio of transformative medicines and is well-aligned with our demonstrated expertise in hematology, neurology and critical care...We believe Andexxa has the potential to become the global standard of care for patients who experience life-threatening bleeds while taking Factor Xa inhibitors apixaban and rivaroxaban. By leveraging Alexion's strong operational and sales infrastructure and deep relationships in hospital channels, we are well positioned to expand the number of patients helped by Andexxa, while also driving value for shareholders."

The firms advised that "under the terms of the merger agreement, a subsidiary of Alexion will commence a tender offer to acquire all of the outstanding shares of Portola's common stock at a price of $18 per share in cash." Alexion plans to fund the purchase with existing cash on hand and the transaction is expected to close in Q3/20. The purchase is subject to approval by a majority interest of Portola's common stockholders tendering their shares along with ordinary closing conditions and regulatory approvals. The company noted that "following successful completion of the tender offer, Alexion will acquire all remaining shares not tendered in the offer at the same price of $18 per share through a merger."

Alexion is a global biopharmaceutical company based in Boston, Mass., with offices in 50 countries worldwide. The company states that it has been "the global leader in complement biology and inhibition for more than 20 years and that it has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor antibody-positive generalized myasthenia gravis and neuromyelitis optica spectrum disorder."

Portola is headquartered in South San Francisco, Calif., and is a commercial-stage biopharmaceutical company focused on treating patients with serious blood-related disorders. Specifically, the company is engaged in developing and commercializing novel therapeutics in order to advance the fields of thrombosis and other hematologic conditions. The firm listed that its first two commercialized products are Andexxa^® and Bevyxxa^® (betrixaban), and that it is also advancing and developing cerdulatinib, a SYK/JAK inhibitor for use in treatment of hematologic cancers.

Portola Pharmaceuticals started off the day with a market capitalization of around $609.0 million with approximately 78.5 million shares outstanding and a short interest of about 23.0%. PTLA shares opened 130% higher today at $17.85 (+$10.09, +130.03%) over yesterday's $7.85 closing price. The stock has traded today between $17.71 and $17.91 per share and is currently trading at $17.83 (+$10.07, +129.77%).

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Source: Streetwise Reports   05/05/2020

Commercial-stage biotechnology company Portola Pharmaceuticals Inc. (PTLA:NASDAQ), which focuses on blood-related disorders, and global biopharmaceuticals firm Alexion Pharmaceuticals Inc. (ALXN:NASDAQ) announced that they have entered into a definitive merger agreement for Portola to be acquired by Alexion.

The acquisition is said to provide a key addition to Alexion's diversified commercial portfolio. The report indicated that the merger agreement has already been unanimously approved each of the company's boards of directors.

The report explained that "Portola's commercialized medicine, Andexxa^® [coagulation factor Xa (recombinant), inactivated-zhzo], marketed as Ondexxya^® in Europe, is the first and only approved Factor Xa inhibitor reversal agent, and has demonstrated transformative clinical value by rapidly reversing the anticoagulant effects of Factor Xa inhibitors rivaroxaban and apixaban in severe and uncontrolled bleeding."

Portola's President and CEO Scott Garland commented, "In developing and launching Andexxa, Portola has established a strong foundation for changing the standard of care for patients receiving Factor Xa inhibitors that experience a major, life-threatening bleed. Andexxa rapidly reverses the pharmacologic effect of rivaroxaban and apixaban within two minutes, reducing anti-Factor Xa activity by 92 percent...Given their enhanced resources, global footprint and proven commercial expertise, we look forward to working with Alexion to maximize the value of Andexxa. With their commitment to commercial excellence, together, we will be able to drive stronger utilization of Andexxa, increase penetration and accelerate adoption in the critical care setting."

Ludwig Hantson, Ph.D., CEO of Alexion, remarked, "The acquisition of Portola represents an important next step in our strategy to diversify beyond C5. Andexxa is a strategic fit with our existing portfolio of transformative medicines and is well-aligned with our demonstrated expertise in hematology, neurology and critical care...We believe Andexxa has the potential to become the global standard of care for patients who experience life-threatening bleeds while taking Factor Xa inhibitors apixaban and rivaroxaban. By leveraging Alexion's strong operational and sales infrastructure and deep relationships in hospital channels, we are well positioned to expand the number of patients helped by Andexxa, while also driving value for shareholders."

The firms advised that "under the terms of the merger agreement, a subsidiary of Alexion will commence a tender offer to acquire all of the outstanding shares of Portola's common stock at a price of $18 per share in cash." Alexion plans to fund the purchase with existing cash on hand and the transaction is expected to close in Q3/20. The purchase is subject to approval by a majority interest of Portola's common stockholders tendering their shares along with ordinary closing conditions and regulatory approvals. The company noted that "following successful completion of the tender offer, Alexion will acquire all remaining shares not tendered in the offer at the same price of $18 per share through a merger."

Alexion is a global biopharmaceutical company based in Boston, Mass., with offices in 50 countries worldwide. The company states that it has been "the global leader in complement biology and inhibition for more than 20 years and that it has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor antibody-positive generalized myasthenia gravis and neuromyelitis optica spectrum disorder."

Portola is headquartered in South San Francisco, Calif., and is a commercial-stage biopharmaceutical company focused on treating patients with serious blood-related disorders. Specifically, the company is engaged in developing and commercializing novel therapeutics in order to advance the fields of thrombosis and other hematologic conditions. The firm listed that its first two commercialized products are Andexxa^® and Bevyxxa^® (betrixaban), and that it is also advancing and developing cerdulatinib, a SYK/JAK inhibitor for use in treatment of hematologic cancers.

Portola Pharmaceuticals started off the day with a market capitalization of around $609.0 million with approximately 78.5 million shares outstanding and a short interest of about 23.0%. PTLA shares opened 130% higher today at $17.85 (+$10.09, +130.03%) over yesterday's $7.85 closing price. The stock has traded today between $17.71 and $17.91 per share and is currently trading at $17.83 (+$10.07, +129.77%).

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

A recent study compared the decentralised treatment of pharmaceutical contaminants in wastewater at hospitals with centralised treatment at conventional and upgraded wastewater plants. The results suggest that additional (post) treatments may not always provide significant benefits.

A recent study compared the decentralised treatment of pharmaceutical contaminants in wastewater at hospitals with centralised treatment at conventional and upgraded wastewater plants. The results suggest that additional (post) treatments may not always provide significant benefits.

The release of pharmaceutically active compounds (PhACs) in waste water from treatment plants (WWTPs) is currently not regulated anywhere in the world, with the exception of a few plants in Switzerland. Yet thousands of PhACs or their by-products — excreted by humans — can be found in waste water and some of these may harm biodiversity when released into waterways. For example diclofenac and oxazepam may have negative effects on aquatic species.

A comprehensive analysis of pharmaceuticals in Spanish wastewater has indicated that they are widespread pollutants. The majority of pharmaceuticals present in incoming wastewater were still present in both treated water and in the river waters receiving the treated water.

A recent study compared the decentralised treatment of pharmaceutical contaminants in wastewater at hospitals with centralised treatment at conventional and upgraded wastewater plants. The results suggest that additional (post) treatments may not always provide significant benefits.

A new tool has been developed which highlights ‘hot spots’ of pharmaceutical pollution in Europe, where human health and aquatic environments could potentially be affected. The results suggest that the substances and locations posing the greatest risk are not the same for the aquatic environment as for human health.

Changes in complex microbial communities known as ‘biofilms’ at the bottom of rivers can reveal the effects of pesticide and pharmaceutical pollution of river water, according to a recent study. Painkillers and anti-inflammatory drugs were found to have a significant effect on the structure and functioning of the biofilms.

Controls on pharmaceutical production in the EU should be changed to guard against the spread of antibiotic resistance, protect wildlife and improve transparency in the industry, a team of scientists from Sweden and the UK recommends. The scientists propose 10 changes to the environmental risk assessment (ERA) of pharmaceuticals.

Among the several treatments being proposed to fight Covid-19 are drugs used to attack parasites. One such candidate that has been much in the news is hydroxychloroquine.

ET takes a look at the vaccines that have moved from the pre-clinical to clinical phase of development for Covid-19, a step closer to finding a preventative drug against the deadly virus

Shares of CNS Pharmaceuticals Inc. (CNSP) are rising over 7% in pre-market today, after the company announced that it has filed an application with the U.S. FDA to receive Orphan Drug Designation or ODD for its lead product Berubicin.

Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA) investors will be delighted, with the company turning in some strong...

(United States Federal Circuit) - Affirmed the bench trial finding that valid patents still existed in a longstanding pharmaceutical drug called Aveed after defendant Custopharm was sued for patent infringement by Endo Pharmaceuticals and Bayer after seeking FDA approval to produce a generic version of Aveed.

(United States Federal Circuit) - Affirmed a finding of patent claim invalidity involving certain claims related to a drug distribution system for tracking prescriptions of sensitive drugs, such as those with addictive properties. In affirming, the Federal Circuit held that the Patent Trial and Appeal Board did not err and that its determination, on inter partes review, that the patents were invalid was obvious.

(United States Federal Circuit) - Affirmed that tribal sovereign immunity could not be asserted in a patent proceeding. A pharmaceutical company involved in a dispute over an eye medication patent transferred the title of its patent to a Native American tribe, which then moved to terminate the patent proceeding on the basis of sovereign immunity. Concluding that tribal sovereign immunity cannot be asserted in inter partes review, the Federal Circuit affirmed the denial of the Tribe's motion to terminate the proceeding.

(United States Supreme Court) - Held that an inventor's sale of an invention to a third party who is obligated to keep the invention confidential can qualify as prior art for purposes of determining the patentability of the invention. The dispute here involved two pharmaceutical companies that disagreed about whether a certain drug was under patent; one of the companies wanted to market a generic version of it. Justice Thomas delivered the unanimous opinion.

(United States Federal Circuit) - Affirmed the bench trial finding that valid patents still existed in a longstanding pharmaceutical drug called Aveed after defendant Custopharm was sued for patent infringement by Endo Pharmaceuticals and Bayer after seeking FDA approval to produce a generic version of Aveed.

(United States Federal Circuit) - Affirmed a finding of patent claim invalidity involving certain claims related to a drug distribution system for tracking prescriptions of sensitive drugs, such as those with addictive properties. In affirming, the Federal Circuit held that the Patent Trial and Appeal Board did not err and that its determination, on inter partes review, that the patents were invalid was obvious.

(United States Federal Circuit) - Affirmed that tribal sovereign immunity could not be asserted in a patent proceeding. A pharmaceutical company involved in a dispute over an eye medication patent transferred the title of its patent to a Native American tribe, which then moved to terminate the patent proceeding on the basis of sovereign immunity. Concluding that tribal sovereign immunity cannot be asserted in inter partes review, the Federal Circuit affirmed the denial of the Tribe's motion to terminate the proceeding.

(United States Supreme Court) - Held that an inventor's sale of an invention to a third party who is obligated to keep the invention confidential can qualify as prior art for purposes of determining the patentability of the invention. The dispute here involved two pharmaceutical companies that disagreed about whether a certain drug was under patent; one of the companies wanted to market a generic version of it. Justice Thomas delivered the unanimous opinion.

(Supreme Court of California) - Affirming the Court of Appeals determination that the manufacturer of a name brand drug whose labeling directs the warnings provided on its generic bioequivalent's packaging owes a duty of reasonable care to the consumers of the generic drug and that the liability for potential negligence doesn't automatically terminate upon transfer of the company's rights in the name brand drug to a successor manufacturer.

(United States Federal Circuit) - Affirming the District Court's determination that a proposed generic nasal spray would not infringe the patents of a company manufacturing the Nasonex nasal product.

(United States Ninth Circuit) - Partly affirming, partly vacating, and remanding the district court dismissal of a False Claims Act action brought against three pharmaceutical companies in a case involving off-label drug use and kickbacks to doctors because claims were substantially similar to those that had already been publicly disclosed, vacating to determine whether the situation qualified for the original source exception.

(United States Federal Circuit) - Affirming the decision of the district court holding, after a bench trial, that the asserted claims of a patent relating to the treatment of schizophrenia with iloperidone administered based on the genotype of the patient were infringed and not invalid.

(United States Federal Circuit) - Affirming that a chemical compound that mirrored a patented chemical compound was encompassed by the description that only portrayed one of the arrangements in the claim.

(United States Federal Circuit) - Vacating the Patent Trial and Appeal Board's dismissal of an interference claim for lack of standing and remanding for further proceedings because the description of a method for removing hair using nanoparticles to damage hair follicles was a sufficient written description under the Patent Act because although the description only gave optical density rather than particles per ml, this was enough of a disclosure to convey to those skilled in the art that the inventor had possession of the claimed subject matter.

(United States Federal Circuit) - Affirming the decision of the Patent Trial and Appeal Board in an inter partes review proceeding of patents relating to boron-containing small molecules used to treat fungal infections, holding that all of the claims of a patent owned by a company were unpatentable for obviousness.

(United States Federal Circuit) - Affirmed the bench trial finding that valid patents still existed in a longstanding pharmaceutical drug called Aveed after defendant Custopharm was sued for patent infringement by Endo Pharmaceuticals and Bayer after seeking FDA approval to produce a generic version of Aveed.

(United States Federal Circuit) - Affirmed a finding of patent claim invalidity involving certain claims related to a drug distribution system for tracking prescriptions of sensitive drugs, such as those with addictive properties. In affirming, the Federal Circuit held that the Patent Trial and Appeal Board did not err and that its determination, on inter partes review, that the patents were invalid was obvious.

(United States Federal Circuit) - Affirmed that tribal sovereign immunity could not be asserted in a patent proceeding. A pharmaceutical company involved in a dispute over an eye medication patent transferred the title of its patent to a Native American tribe, which then moved to terminate the patent proceeding on the basis of sovereign immunity. Concluding that tribal sovereign immunity cannot be asserted in inter partes review, the Federal Circuit affirmed the denial of the Tribe's motion to terminate the proceeding.

(United States Second Circuit) - Held that it was proper to remand to New York state court a case in which a labor union health plan sought disclosure of a patent dispute settlement agreement between pharmaceutical companies and the generic manufacturer of the EpiPen. Affirmed the district court's remand order, in this special proceeding under New York law seeking pre‐action disclosure.

(United States Supreme Court) - Held that an inventor's sale of an invention to a third party who is obligated to keep the invention confidential can qualify as prior art for purposes of determining the patentability of the invention. The dispute here involved two pharmaceutical companies that disagreed about whether a certain drug was under patent; one of the companies wanted to market a generic version of it. Justice Thomas delivered the unanimous opinion.

Allegations about Valeant’s practices and its own disclosures while under pressure cause one to wonder.

These three flights transported over 50 Tonnes of cargo including pharmaceuticals, fruits and vegetables in the belly and cabin.

Alexion has announced it is to acquire Boston-based blood disorder specialist Portola Pharmaceuticals in a transaction to the value of $1.41 billion in cash.

Novartis Pharmaceuticals Corporation has agreed to pay $422.5 million to resolve criminal and civil liability arising from the illegal marketing of certain pharmaceutical products.

Kos Pharmaceuticals, a subsidiary of Abbott Laboratories, has agreed to pay more than $41 million to resolve criminal and civil liability arising from conduct relating to its drugs Advicor and Niaspan.

Drug manufacturer Forest Pharmaceuticals Inc. was sentenced today by U.S. District Judge Nancy Gertner to pay a criminal fine of $150 million and forfeit assets of $14 million.

Dava Pharmaceuticals Inc. has agreed to pay the United States $11 million to settle allegations that it violated the False Claims Act by misreporting drug prices in order to reduce its Medicaid Drug Rebate obligations, the Justice Department announced today.

Andrew Strempler, a Canadian citizen, pleaded guilty today in the Southern District of Florida for his role in a scheme to defraud consumers purchasing pharmaceuticals online, the Justice Department announced. Strempler faces up to five years in prison, a forfeiture of $300,000, a fine and restitution.

Two Pakistani nationals have been indicted by a federal grand jury in the District of Columbia on charges alleging that they operated Internet sites that illegally shipped pharmaceuticals from Pakistan and the United Kingdom to customers in the United States.