Ashley Roberts

	On March 17, 2015, Kite Pharma announced that it would expand its T-cell capabilities with the acquisition of privately-held Dutch company, T-Cell Factory B.V. (TCF), which has now been renamed Kite Pharma EU. As part of the €20 million (approximately $21 million USD) acquisition, TCF brings Kite Pharma TCR-GENErator, its proprietary technology platform that “rapidly and systematically discovers, characterizes, and selects tumor-specific TCRs [T-cell receptors] of therapeutic value,” according to a press release.

	The acquisition also allows Kite Pharma to move further into the European market by providing access to European clinical manufacturing facilities. Earlier in 2015, Kite Pharma 

 that it would further its T-cell platform with commercial manufacturing facility expansion in California. The addition of two facilities would support clinical trials, as well of the commercial launch and supply of KTE-C19. The lead investigational drug is an anti-CD19 CAR T-cell therapy in which the patients’ T-cells are genetically modified to express a CAR that will target CD19 (a protein found on the cell surface of B cell lymphomas and leukemias), according to a 

	"The acquisition of TCF and its novel discovery and development platform provides Kite with a strong position in TCR gene therapy for cancer. In addition, with our strategic plans for expanding clinical operations to ex-US sites, Kite's relationship with NKI, an internationally renowned research and clinical institution, provides an important operational platform and potential access to investigators, clinical sites and manufacturing facilities in Amsterdam," said Arie Belldegrun, MD, FACS, president and CEO of Kite Pharma, in a press release.

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Kite Pharma announced that it acquired T-Cell Factory B.V. in an effort to strengthen its T-cell portfolio.

Kite Pharma Inks Deal to Spur Move into European T-Cell Market

	The Biotechnology Industry Organization (BIO) and the Colorado BioScience Association (CBSA) want to make it possible for patients to access interchangeable biologic medicines, they just need one signature to help get the legislation passed. CBSA, who just recently passed Senate Bill 71 (also passed by Senate), along with BIO are encouraging Colorado’s Governor Hickenlooper to sign the bill to keep biologic interchangeability transparent for patients.

	“Senate Bill 71 enjoys the support of physicians across the country, patient groups, and both innovator biologic and biosimilar manufacturing companies. This bill includes transparent communication on all biologic medicines dispensed in order to maintain a consistent and complete medical record,” said Jim Greenwood, BIO’s president and CEO, in a press release.

	FDA has the final say in biologic interchangeability approval, however, state legislation decides whether or not a product may be substituted in place of a doctor’s prescription and if pharmacists must inform patients and doctors of the interchangeability. As is written in the 

, the pharmacist must inform the purchaser if he or she is administering an interchangeable biological product, however, the pharmacist is not permitted to substitute an interchangeable biological product unless it costs the purchaser less than the drug or biological product prescribed. If the prescribed biological product is not in stock, and the interchangeable biological product is priced higher, the pharmacist may give the higher-priced biologic after informing the purchaser.

	“This legislation will benefit Coloradoans when the first interchangeable biologics are approved by the FDA. When they become available, these therapies will be safe, effective, and similar to innovator biologics. Furthermore, they will provide patients with more opportunities to address their unmet medical needs, particularly severely ill patients who rely on cutting-edge medical treatments,” said April Giles, president and CEO of CBSA, in a press release.

	The first biosimilar was approved in the US by FDA in the first week of 

, and stated that it believes we will see interchangeable biosimilar product approvals starting this year. Urging legislators to pass this bill will help to keep transparency a part of the patient care process when giving interchangeable biologic medicines.

BIO and the Colorado BioScience Association urge Colorado Governor Hickenlooper to sign a bill that will help patients gain access to interchangeable biologic products following FDA approvals.

BIO Encourages Transparency with Support of Biologic Interchangeability Bill

	On March 10, 2015 Zogenix announced an agreement to sell Zohydro ER (hydrocodone bitartrate) to Pernix Therapeutics. As part of the agreement, Zogenix will pay Pernix $100 million up front ($30 million in cash, $20 million in common stock, and $50 million in short term promissory note) with the potential for regulatory and sales milestones up to $283.5 million.

	The agreement will allow Zogenix to shift its focus to late-stage central nervous system clinical pipeline featuring two potential Phase III drugs: ZX008, which has orphan drug designation in the US and EU and is for the treatment of Dravet syndrome; and Relday, a long-acting injectable risperidone formulation for the management of schizophrenia.

blog reported in April 2014 on the 2013 controversy when FDA approved Zohydro, causing state legislatures to try and ban the drug outright because of its hydrocodone’s addictive qualities. There was so much controversy surrounding the drug that Zogenix released a page on its website, 

Let’s Get the Facts Straight about Zohydro ER Extended Release Capsules

. The page sets out to debunk myths about the drug and reassure patients that the drug is the same potency as other opioids on the market, and the highest dose is significantly lower than the highest dose of oxycodone or morphine. The company defended its drug in 2014 by stating “Zohydro ER deserves to be judged on its medical merits and the benefits it provides to patients suffering from chronic pain, not on the basis of media reports. Over the coming weeks, we will continue to report and distribute accurate information to address common misperceptions about Zohydro ER”.

Zogenix agreed to sell Zohydro, its controversial pain medication, to Pernix for $100 million.

Zogenix Ditches Its Controversial Drug Zohydro

	FDA announced on Feb. 25, 2015 that it approved the use of Avycaz (ceftazidime-avibactam), Actavis’ antibiotic for drug-resistant bacteria, also called superbugs. The antibiotic is designed to treat adults with complicated intra-abdominal infections (cIAI) when used in combination with the generic antibiotic metronidazole. Avycaz is also designated as a standalone medication to treat complicated urinary tract infections (cUTI).

	Avycaz is a fixed-combination drug containing ceftazidime, a previously approved cephalosporin antibacterial drug, and avibactam, a new beta-lactamase inhibitor, according to the press release. This marks the fifth approval of an antibacterial drug product that has been designated by FDA as a Qualified Infectious Disease Product (QIDP), a designation which is given to antibacterial products that treat serious or life-threatening infections under FDA Safety and Innovation Act title Generating Antibiotic Incentives Now. A QIDP designation gives new drugs priority review, as well as an additional five-year marketing exclusivity period. The safety and efficacy of the drug was determined through two Phase II trials, one in cIAI and one in cUTI.

	This approval comes at a time as the word “superbug” has begun circulating through the media more frequently. In February 2015, seven patients at UCLA Medical Center became infected by a potentially fatal group of superbugs, with hundreds exposed to the bacteria, according to the 

. In January 2015, NovoBiotic, Northeastern University, and the University of Bonn 

 a partnership to discover a new class of antibiotics that was identified via new methods. The class of antibiotics is designed to block a microbes’ ability to build cell walls, killing it and inhibiting the bacteria from becoming resistant.

FDA approved Actavis’ antibiotic Avycaz designed to combat drug-resistant bacteria.

Superbug Antibiotic Lands FDA Approval

	On Feb. 25, 2015, a Philadelphia court ruled that Johnson & Johnson (J&J) failed to adequately warn about the potential for the antipsychotic drug Risperdal (risperidone) to cause gynecomastia, according to 

. J&J will pay $2.5 million to the first plaintiff, in a long list of thousands of lawsuits that are lined up to go to jury trial alleging that gynecomastia was caused by Risperdal. The plaintiff, a 20-year old autistic man from Alabama, reportedly developed size 46 DD breasts after Risperdal was prescribed to alleviate the irritability caused by his autism.

	In 2013, J&J paid $2.2 billion to settle state and federal criminal and civil charges related to illegally marketing the drug for indications not approved by FDA. Drug companies cannot officially promote drugs off-label.  However, doctors can prescribe them on an off-label basis. The doctor who treated the plaintiff claimed that a sales representative for the drug had repeatedly visited his office promoting the use of Risperdal, but did not mention the severity of side effects, and, when the doctor began prescribing it to the young plaintiff, it had not been approved for use in adolescents. At the time, there were J&J studies that suggested that Risperdal may cause gynecomastia, but this information was not relayed to healthcare providers.

	An attorney for the company argued that the label listed the risks associated with the drugs, but former FDA Commissioner David Kessler testified that the company did not do enough to inform patients and healthcare providers about the risks involved with the drug. Kessler also cited that, in an FDA study of the drug, Risperdal was found to cause higher levels of the hormone prolactin, which suppresses gonadotropin release, producing secondary hypogonadism, subsequently contributing to the development of gynecomastia, according to a 

, some who testified against the defendant alleged that J&J began to promote the use of Risperdal in children, as early as 2003, three years before it was approved for that indication by FDA. While this is the first trial relating the use of Risperdal to gynecomastia that has gone to jury trial, 

 reported in September 2012 that J&J had already settled a lawsuit for the same type of lawsuit, and was expecting hundreds more to come.

Johnson & Johnson will pay $2.5 million to a plaintiff who developed gynecomastia after using Risperdal.

J&J Loses First Jury Trial for Risperdal

	Celgene announced on Feb. 18, 2015 that its cancer drug Revlimid (lenalidomide) was approved by FDA in combination with dexamethasone to treat patients with newly diagnosed multiple myeloma (NDMM). In 2006, Revlimid, in combination with dexamethasone, was approved for use in multiple myeloma patients who had previously received at least one treatment. This announcement comes four days before its previously anticipated approval date.

, US doctors have prescribed Revlimid in new patients on an off-label basis, however, lacking regulatory approvals, Celgene was unable to market the product for this indication. The approval is expected to go through with European regulators in the next few weeks, opening up the market for European physicians who were previously unable to prescribe Revlimid to NDMM patients due to off-label regulations in Europe. Fifty percent of multiple myeloma patients of approximately 93,600 patients living with the disease in Europe and 88,499 in the US are newly diagnosed.

	"The approval of Revlimid as an option for use in all patients with multiple myeloma represents a new paradigm in the management of this disease. We now have clinical evidence demonstrating that starting and keeping newly diagnosed multiple myeloma patients on Revlimid significantly improves progression-free survival,” said Kenneth Anderson, MD, director, Jerome Lipper Multiple Myeloma Center, Dana-Farber/Brigham and Women's Cancer Center, in a press release.

 for the treatment of relapse/refractory 

, which is a type of non-Hodgkin lymphoma wherein the cancer cells make large amounts of an abnormal protein called macroglobulin, according to the American Cancer Society.

Celgene announced that its drug, Revlimid, gained FDA approval for the treatment of newly diagnosed multiple myeloma.