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Monday, July 22, 2019

InvaGen (a Cipla Subsidiary) Gets Final OK for Generic Version of Pfizer’s Lyrica

InvaGen Pharmaceuticals, Inc.(“InvaGen”), a wholly-owned subsidiary of the leading global pharmaceutical company Cipla Limited (BSE: 500087; NSE: CIPLA EQ; hereafter referred to as “Cipla”) announced the receipt of final approval for its Abbreviated New Drug Application (ANDA) for Pregabalin Capsules, 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg from the United States Food and Drug Administration (US FDA).
InvaGen’s Pregabalin Capsules, 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg is AB-rated generic therapeutic equivalent version of Pfizer‘s Lyrica®. Pregabalin capsules are indicated for:
  • Management of neuropathic pain associated with diabetic peripheral neuropathy
  • Management of postherpetic neuralgia
  • Adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older
  • Management of fibromyalgia
  • Management of neuropathic pain associated with spinal cord injury
According to IQVIA (IMS Health), Lyrica® had US sales of approximately $5.4 Billion for the 12-month period ending March 2019. The product is available for shipping immediately.

DaVita Announces Prelim 2Q Results, Updated Guidance for Fiscal Year 2019

DaVita Inc. (NYSE: DVA) (“DaVita” or “Company”), today announced preliminary second quarter 2019 financial and operating results and updated guidance for fiscal year 2019.
The Company is releasing this information to provide investors with updated financial information in conjunction with its anticipated modified “Dutch auction” tender offer for up to $1.2 billion of its common stock at a price per share not less than $53.50 nor greater than $61.50. The tender offer will commence today and will expire at 12:00 midnight, New York Citytime, at the end of the day on August 16, 2019, unless extended by the Company or otherwise terminated, and will be conditioned upon successful completion of a bank financing on terms reasonably satisfactory to the Company as well as certain other conditions detailed in the tender offer documents to be filed with the Securities and Exchange Commission (“SEC”) today.
The aforementioned bank financing is expected to consist of the following:
  • $1.0 billion secured revolving loan facility;
  • $1.75 billion secured term loan A facility with a delayed draw feature; and
  • $2.5 billion secured term loan B facility.
The Company expects to use proceeds from the bank financing to repay amounts outstanding under the Company’s current credit facility, call the Company’s outstanding 5.75% Senior Notes due 2022 (the “Senior Notes”), fund the tender offer, and add cash to the balance sheet for potential future share repurchases, acquisitions, and other general corporate purposes. This press release does not constitute a call notice for the Senior Notes. The Company expects the call notice for the Senior Notes to be issued following completion of the bank financing.
Preliminary Second Quarter Financial and Operating Results
DaVita expects operating income for the second quarter of 2019 to be between $460 millionand $465 million. Included in this operating income is the Company’s expectation of approximately $40 million in operating income attributable to calcimimetics.
In the Company’s U.S. dialysis and related lab services segment, the Company expects to report:
  • Second quarter non-acquired treatment growth of 2.1%, with 7,520,587 treatments during the quarter.
  • Revenue per treatment of approximately $350, an increase of approximately $1.60 from the first quarter of 2019 driven by fluctuations in quarterly revenue, partially offset by a decline in revenue from calcimimetics.
  • Cost per treatment decrease of approximately $9 from the first quarter of 2019, driven primarily by reduced calcimimetics expense and reduced labor and benefit expense due to strong productivity.
From the date of the Company’s last earnings call on May 7, 2019, through July 17, 2019, the Company repurchased a total of 6,274,181 shares of its common stock for approximately $350 million at an average cost of $55.78 per share. Effective as of July 17, 2019, the Company’s Board of Directors terminated the remaining share repurchase authorization and approved a new share repurchase authorization of $2.0 billion. This new share repurchase authorization has no expiration date.
Updated 2019 Outlook
The Company is updating its adjusted operating income (a non-GAAP financial measure) guidance for fiscal year 2019 to a range of $1.64 billion to $1.70 billion. The Company’s prior guidance for adjusted operating income for fiscal year 2019 was $1.54 billion to $1.64 billion.
The substantial majority of the increase in the adjusted operating income guidance is a result of the Company’s improved expectation of profit from calcimimetics, which is not expected to recur in 2020, and the remainder is from the ongoing operating performance.

DaVita Commences Self-Tender Offer

DAVITA INC. (NYSE: DVA), “DaVita,” a Fortune 500®health care provider focused on transforming care delivery to improve quality of life for patients around the globe and the largest provider of kidney care services in the U.S., announced today that it has commenced a modified “Dutch auction” tender offer for up to $1.2 billion of its common stock at a price per share not less than $53.50 and not greater than $61.50. The tender offer will expire at 12:00 midnight, New York City time, at the end of the day on August 16, 2019, unless extended by DaVita or otherwise terminated. Tenders of shares must be made on or prior to the expiration of the tender offer and may be withdrawn at any time prior to the expiration of the tender offer, in each case, in accordance with the procedures described in the tender offer materials.
A modified “Dutch auction” tender offer allows shareholders to indicate how many shares and at what price within DaVita’s specified range they wish to tender. Based on the number of shares tendered and the prices specified by the tendering shareholders, DaVita will determine the lowest price per share within the specified range that will enable DaVita to purchase shares having an aggregate purchase price of up to $1.2 billion. DaVita also reserves the right, in the event that more than $1.2 billion of its shares are tendered in the tender offer at or below the purchase price, to purchase at its option up to an additional number of shares of common stock not to exceed 2% of the total number of its shares of common stock outstanding (exclusive of any shares of common stock held by or for DaVita’s account or by or for the account of any of DaVita’s subsidiaries) without amending or extending the tender offer. All shares purchased by DaVita in the tender offer will be purchased at the same price. Shareholders whose shares are purchased in the tender offer will be paid the determined purchase price in cash, less any applicable withholding taxes and without interest, after the expiration of the tender offer.
DaVita expects to enter into a new credit agreement and finance the share purchases in the tender offer with borrowings under such new credit agreement. The tender offer is not conditioned upon any minimum number of shares being tendered, but is subject to the successful execution of the new credit agreement with terms reasonably satisfactory to DaVita and total lender commitments of not less than $5.25 billion. The tender offer documents also contain tendering instructions and a complete explanation of the tender offer’s terms and conditions.
The dealer manager for the tender offer is Credit Suisse Securities (USA) LLC. Georgeson LLC is serving as information agent for the tender offer and Computershare is serving as the depositary for the tender offer.

LabCorp Expands Consumer-Initiated Test Offering

LabCorp® (NYSE: LH), a leading global life sciences company, today announced a significant expansion to its Pixel by LabCorp™ platform. The new offering allows consumers to purchase testing online, visit a convenient LabCorp patient service center (PSC) for specimen collection by a LabCorp phlebotomist, and receive confidential results through a secure online portal. The tests are performed in LabCorp’s laboratories, using the same equipment and processes as the testing that clinicians order for their patients during in-office visits. With the newly expanded Pixel by LabCorp, consumers have more options to access testing through the same world-class lab trusted by more than 400,000 physicians across the U.S.
“Consumers are becoming increasingly interested and engaged in monitoring their health and wellness,” said David P. King, LabCorp’s chairman and CEO. “LabCorp continues to change the way care is provided by creating new channels to deliver our offerings. Expanding Pixel by LabCorp to our PSCs allows consumers to choose phlebotomist collection for their self-directed testing. By meeting patients where they want to be met, we continue to expand access to LabCorp’s high-quality clinical laboratory and to empower consumers to take charge of their health and the health of their families.”
The expanded Pixel by LabCorp platform offers consumers 25 packages, comprised of nearly 90 individual lab tests in categories including general health and wellness; heart health; diabetes and kidney function; hormones, thyroid and fertility; and vitamins and nutrition. There are a variety of packages available, such as Women’s Health, Men’s Health, Thyroid Health, and Anemia. LabCorp will continue to expand the Pixel test menu, as additional offerings are planned for the near future.
Consumers shop for their preferred tests at www.Pixel.LabCorp.com and make purchases using a credit card. Pricing is transparent; insurance companies are not billed; and a dedicated customer support team is available to respond to questions by phone and email. Each purchase includes review and issuance of an order for the approved testing by an independent physician. Consumers can then schedule an appointment (or walk-in) at one of LabCorp’s nearly 2,000 PSCs, including the increasing number of LabCorp at Walgreens locations. Results are delivered in less than a week, and in many cases, the following day, through the consumer’s secure online Pixel by LabCorp account.
If a lab result indicates that prompt medical attention may be appropriate, the consumer will be contacted by a third-party physician group. Reports use color-coding and iconography to make them easy to understand, and the reports can be downloaded, printed, and shared with the consumer’s physician.

Baxter: FDA OKs First and Only Ready-To-Use Insulin for IV Infusion

Baxter International, Inc. (NYSE:BAX), a global leader in sterile medication production and delivery, today announced the U.S. Food and Drug Administration (FDA) approval of Myxredlin (Insulin Human in 0.9% Sodium Chloride Injection). Myxredlin(pronounced mix-RED-lin) is the first and only ready-to-use insulin for IV infusion in the hospital and other acute care settings and features an extended shelf life of 30 days at room temperature (77 degrees F [25 degrees C]) or 24 months if refrigerated (36 degrees F to 46 degrees F [2 degrees C to 8 degrees C]) in the original carton to protect from light. Myxredlin is provided in a standardized concentration of 100 units/100 mL in a flexible plastic container. This innovative presentation helps ensure Myxredlin delivers a consistent, stable and predictable concentration with every administration, which is a key consideration for patient safety.
“Insulin is in the top five drug classes involved with medication errors, and more than 30 percent of those errors result in patient harm,”1 said Robert Felicelli, president, Pharmaceuticals, Baxter. “When a patient requires intravenous insulin in the hospital, pharmacists have to manually admix insulin for treatment. With the launch of Myxredlin, clinicians will have access to a convenient, reliable presentation of ready-to-use insulin that can help ensure faster delivery to patients, streamlined workflow for pharmacists and nurses, and less waste for hospitals.”
Myxredlin is indicated for use as a short-acting human insulin to improve glycemic control in adults and pediatric patients with diabetes mellitus. Myxredlin is intended for use only in acute care settings under medical supervision.

Galmed started at Buy by Laidlaw

Target $25

Microbot Medical started at Buy by Wainwright

 Target $10