FDA Probes Multistate Cyclospora Illnesses Tied to McDonald’s Salad Mix

The FDA, CDC, along with state and local officials are investigating a multi-state outbreak of cyclosporiasis illnesses likely linked to salads from McDonald’s (NYSE: MCD) restaurants.

Update – August 23, 2018

As of August 23, 2018, a total of 507 laboratory-confirmed cases of Cyclospora infection were reported in people who consumed salads from McDonald’s restaurants; the cases were reported by 15 states and New York City. The investigation is ongoing and the FDA is currently reviewing distribution and supplier information for romaine and carrots.

Consumers who have symptoms of cyclosporiasis should contact their health care provider to report their symptoms and receive care.

https://bit.ly/2wls2fr

Veeva raises FY19 adjusted EPS view to $1.47-$1.48 from $1.36-$1.38

Consensus $1.37. Raises FY19 revenue view to $840M-$843M from $826M-$830M, consensus $829.39M.

https://bit.ly/2MsEgho

Akorn rift with Fresenius continues

Shares of Akorn (NASDAQ:AKRX) dropped by nearly 24% as investors prepared for a hearing scheduled for today regarding its spat with Fresenius, which in April pulled out of an agreement to acquire the generic drug manufacturer.

Fresenius nixed the merger agreement after uncovering “blatant fraud at the very top level of Akorn’s executive team, stunning evidence of blatant and pervasive data integrity violations,” according to reporting by Reuters on the original court filing. That likely doesn’t leave much room for Akorn to have a good argument about why the merger should proceed, and news trickling out of the courtroom today seems to indicate just that.

As of 3:47 p.m. EDT, the stock had settled to a 17.3% loss.

Investors were right to worry. According to Bloomberg, the judge in the case said Fresenius had a powerful case that Akorn violated the merger agreement, although the judge also said he had a lot of work to do before deciding the case. Nonetheless, it doesn’t look good for Akorn:

AKRX DATA BY YCHARTS.

While investors still need more details about the results of the hearing and future direction of the proceedings, it’s pretty much a foregone conclusion that Akorn and Fresenius will not be merging.

It goes without saying that these allegations of fraud are very serious and shouldn’t be overlooked by investors. If true, they cast doubt on the integrity of operations. At the very least, they give both institutional and individual investors reason to park their money elsewhere — and that seems to be what has happened so far in 2018. The best-case scenario now would be for the hearing to be decided and for all parties to move forward, but that will take time to play out.

https://bit.ly/2BInxSp

Cargill Recalls Ground Beef Products due to Possible E. coli Contamination

Cargill Meat Solutions, a Fort Morgan, Colo. establishment, is recalling approximately 25,288 pounds of ground beef products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The ground beef items were produced on Aug. 16, 2018. The following products are subject to recall: [View Labels (PDF Only)]

• 10-lb. chubs of ‘EXCEL 93/7 FINE GRIND GROUND BEEF’ with ‘Use/Frz. By Sep 05’ on the chub label and a ‘PACK DATE 08/16/2018’ on the box label.

The products subject to recall bear establishment number ‘EST. 86R’ inside the USDA mark of inspection. These items were shipped to warehouses in California and Colorado.

The problem was discovered on Aug. 22 by the establishment when they reviewed their records and determined that the product may be associated with product that was presumptive positive for E. coli O157:H7. The company then notified FSIS. There have been no confirmed reports of adverse reactions due to consumption of these products.

Anyone concerned about an illness should contact a healthcare provider. E. coli O157:H7 is a potentially deadly bacterium that can cause dehydration, bloody diarrhea and abdominal cramps 2-8 days (3-4 days, on average) after exposure the organism. While most people recover within a week, some develop a type of kidney failure called hemolytic uremic syndrome (HUS). This condition can occur among persons of any age but is most common in children under 5-years old and older adults. It is marked by easy bruising, pallor, and decreased urine output. Persons who experience these symptoms should seek emergency medical care immediately.

FSIS is concerned that some product may be frozen and in consumers’ refrigerators or freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list will be posted on the FSIS website at www.fsis.usda.gov/recalls.

FSIS advises all consumers to safely prepare their raw meat products, including fresh and frozen, and only consume ground beef that has been cooked to a temperature of 160°F. The only way to confirm that ground beef is cooked to a temperature high enough to kill harmful bacteria is to use a food thermometer that measures internal temperature, http://1.usa.gov/1cDxcDQ.

Consumers with questions about the recall can call 1-844-419-1574. Members of the media with questions about the recall can contact Michael Martin, Cargill’s Director of Communications, at (316) 291-2126.

https://bit.ly/2wmbjc6

FDA approves Shire drug for rare swelling disorder

The U.S. Food and Drug Administration on Thursday approved a first of its kind drug from Shire Plc to treat patients aged 12 and older suffering from a rare hereditary disease that causes swelling.

The drug, Takhzyro, is expected to bring in blockbuster sales for Shire, and is important to Japan’s Takeda Pharmaceutical Co Ltd, which plans to buy the Dublin-based rare disease specialist for $62 billion.

The monoclonal antibody, previously known by its chemical name lanadelumab, was approved https://www.fda.gov/Drugs/DrugSafety/ucm618261.htm?utm_campaign=FDA%20approves%20new%20treatment%20for%20hereditary%20angioedema%20%28HAE%29&utm_medium=email&utm_source=Eloquato treat patients with types I and II hereditary angioedema (HAE), a disease that affects about 1 in 50,000.

There are only a handful of treatments available for HAE, including some from Shire. The disease affects people who have low levels of a certain protein and results in episodes of severe swelling in different areas such as the stomach, limbs, face and throat.

https://bit.ly/2LnegP0

Global Blood nabs Roche dropped heart med for sickle cell disease pipeline

A discontinued heart disease drug may find new life as a treatment for sickle cell disease, with Roche handing off development of its antibody inclacumab to Global Blood Therapeutics.

GBT acquired the worldwide rights to the antibody for $2 million upfront, and signed on to pay about $125 million down the line, plus royalties, if inclacumab is approved to treat vaso-occlusive crises, the painful episodes caused when blood flow is obstructed by sickled red blood cells.

Roche previously completed clinical studies evaluating the safety and pharmacokinetics of inclacumab in more than 500 patients, but halted its development in coronary artery disease after a phase 2 trial.

“We have been working diligently to diversify our product pipeline through both internal research and external business development efforts and are excited to have entered into this agreement for inclacumab,” said Ted Love, M.D., president and CEO of GBT. “Inclacumab is an ideal complement to voxelotor, our lead investigational oral, once-daily therapy, in phase 3 clinical development for SCD.”

Inclacumab is a fully human monoclonal antibody antagonist that targets P-selectin, a cell adhesion protein found lining the walls of blood vessels and on the surface of activated platelets, helping them act as a coagulant in cell-cell interactions.

Voxelotor, meanwhile, is being studied as a therapy for the underlying mechanism of the disease, aiming to help hemoglobin retain more oxygen and keep red blood cells in their normal shape. The phase 3 trial is currently enrolling patients.

According to GBT, the South San Francisco-based company has already begun transferring technology from the Big Pharma to a contract manufacturing organization and is planning to submit an IND application for inclacumab to the FDA in 2021 using Roche’s safety data.

Novartis is developing its own anti-P-selectin antibody, crizanlizumab, for the treatment of vaso-occlusive crises, which it picked up through a $665 million acquisition of Selexys Pharmaceuticals in November 2016.

In December of last year, Novartis described how a phase 2 post-hoc subgroup analysis found crizanlizumab delayed patients’ first on-treatment sickle cell pain crisis compared to placebo—doubling time to their first event, if not more, including in patients taking hydroxyurea.

https://bit.ly/2BGPw4I

Gritstone Oncology files for $80M IPO

Gritstone Oncology, the immuno-oncology upstart that has pocketed more than $194 million in venture capital, is going public. The Bay Area biotech is looking to raise up to $80 million in its IPO, which, along with its sizable war chest, will advance its neoantigen cancer treatments and fund the build-out of its manufacturing facility.

The IPO haul will support Gritstone’s planned phase 1/2 combo trial for its lead asset, GRANITE-001 and preclinical and IND-enabling R&D activities for another candidate, SLATE-001, according to an S-1 filed Thursday.  The GRANITE-001 trial is slated to start in the second half of this year. Gritstone will test the candidate with Bristol-Myers’ Opdivo in patients with common solid tumors, such as metastatic non-small cell lung cancer and gastroesophageal, bladder and colorectal cancers. The two-part phase 1 dose escalation trial will also test GRANITE-001 with systemic Opdivo and localized injection of Yervoy.

Gritstone’s approach involves identifying the tumor-specific neoantigens (TSNAs) an a patient’s tumor cells, using machine learning to determine which candidate is most likely to activate tumor-specific T cells and then treating the patient with personalized synthetic TSNAs. GRANITE-001 is given in two parts—first a priming adenoviral vector, followed by monthly boosters of an RNA vector, each containing the same 20 patient-specific TSNAs.

SLATE-001 uses the same antigen delivery system as GRANITE-001, but instead of personalizing the treatment to each patient, it contains TSNAs that are shared by a subset of cancer patients. It provides an off-the-shelf alternative to GRANITE-001, Gritstone said in the S-1. The company plans to push the treatment into phase 2 in the second half of 2019.

Gritstone burst on the scene in 2015 with a whopping $102 million series A round, following that up in September 2017 with another $97.2 million. In addition to developing its TSNA-based technology, the company has been constructing a personalized immunotherapy manufacturing facility. The 43,000-square-foot industrialized manufacturing facility in Pleasanton, California, will, according to the company, “form the nucleus of Gritstone’s manufacturing program for personalized cancer therapeutics.”

The same day Gritstone filed its S-1, it announced a cell therapy pact with Bluebird Bio, under which the latter handed over $20 million up front in exchange for 10 tumor-specific targets and T-cell receptors (TCRs). Gritstone will use its platform to analyze specific tumor types to find tumor-specific targets and natural TCRs, while Bluebird will apply its cell therapy platforms to these targets. As part of the deal, Bluebird is also investing $10 million in Gritstone and committing to pay “significant” milestones if candidates advance.

https://bit.ly/2wtxcGD