February 09, 2018
logan2

New Crowdfunding and Crowdsourcing Ecosystem Helps Test Ideas, Hire…

Logan: "Entrepreneurs can do more than offer rewards to backers." PLANTSVILLE: Two Connecticut entrepreneurs are taking on the crowd funding and crowdsorcing “space” with a new company Umergence, at umergence.com. CEO and…
February 09, 2018
face sad 512

Poll Reveals What Nutmeggers Want

FAIRFIELD: A new survey reports what most Connecticut residents feel about the state of the state. Sacred Heart University’s Institute for Public Policy poll reports that, “residents were looking for a resolution to the…
February 09, 2018
ENFIELD exterior JUNE2014

Mass Mutual To Close Enfield Location and Consolidate In Springfield and…

After $38 million in improvements just three years ago Mass Mutual is leaving its Enfield location and consolidating operations across the border in Springfield. SPRINGFIELD: MassMutual Insurance is consolidating its…
February 09, 2018
alexionn

Year Results Show Alexion’s Drugs Continue To Show Sales Growth

NEW HAVEN: Even as the company prepares to head north to a new headquarters in Boston, the New Haven portfolio of drugs continues to power ahead for Alexion Pharmaceuticals, Inc. [NYSE:ALXN]. Sales for the company’s lead…

Congress Approves Budget Bill With Plenty For Connecticut

Feb 09, 2018
United States Capitol Building
By: ANA RADELAT | ctmirror.org Washington – In rare bipartisan agreement, Congress on Friday approved a massive budget deal…

Federal Reserve Program Sends Grants to Ten Connecticut Cities

Feb 09, 2018
1200px Federal Reserve from South Boston
BOSTON: Concern about the Federal Reserve raising interest rates in the face of good economic news may have sent the stock…

Tesla Revs Up For Another Pass On Direct Selling

Feb 09, 2018
Tesla Model 3 shiny CleanTechnica EV Report 2017
HARTFORD: Tesla is looking to a new legislative session in their effort to enable its “direct-to-consumer business model”…

Connecticut 48th Among US States For Women Entrepreneurs

Jan 30, 2018
women entrepreneur
The U.S. is home to more than 11.3 million female-owned businesses which employed around nine million people but according…

Quinnipiac Appoints New President To Replace Retiring John Lahey

Jan 31, 2018
olian
HAMDEN: Judy D. Olian has been appointed the ninth president of Quinnipiac University. Olian, is dean and John E. Anderson…

Malloy Seeks Tolls, Gas-tax Hike to Rebuild Transportation Network

Jan 31, 2018
train
By: Keith M. Phaneuf ctmirror.org Gov. Dannel P. Malloy will ask legislators this year to establish electronic tolling on…

New Haven Chamber Chooses New President

Jan 31, 2018
Garrett1 1
NEW HAVEN: Garrett F. Sheehan has been named President of the Greater New Haven Chamber of Commerce and Quinnipiac Chamber…

Klarides: Will Not Run for Governor

Jan 31, 2018
klarides
By: MARK PAZNIOKAS ctmirror.org House Minority Leader Themis Klarides, R-Derby, ended months of speculation about her…

New Haven Biotech Announces US Marketing of New Antibiotic

Jan 31, 2018
baxdela
NEW HAVEN: Melinta Therapeutics, Inc. [NASDAQ:MLNT], is launching intravenous and oral formulations of Baxdela™…

Health

Anti-Marijuana Organization Cites Potential Costs to Legalization

nomarijuana
HARTFORD: While Advocates for legalization of recreational use of Marijuana in Connecticut cite economic benefit to the state an anti-legalization…

Advocates for marijuana sales point to big economic boost

marijuana
By: Keith M. Phaneuf |ctmirror.org Advocates for legalizing recreational marijuana use in Connecticut — and taxing its sales — are hoping a holistic,…

Breaking down this year’s Access Health CT open enrollment

cadeuces obamacare2
By: MACKENZIE RIGG | ctmirror.org In all, 114,134 residents enrolled in private health insurance through the state’s health insurance exchange,…

Wallingford Medical Device Company Launches Product To Control Internal…

zmedica
WALINGFORD: Z-Medica, LLC, a developer of hemostatic devices, announced that QuikClot Control+® approved by the FDA in June of 2017 is now…

Children's Hospital Invests In Mass. Biotech

Biostage 1st patient
HARTFORD: Connecticut Children's Medical Center has made an investment in a small Massachusetts based biotech company Biostage, Inc. [OTCQB:…

State Seeks More Medical Marijuana Sellers

cadeuces
HARTFORD: US Attorney General Jeff Sessions may be trying to arrest the increase in marijuana sales in states across the country, but Connecticut is…

Chester Retirement Community Sold

chestervillage
CHESTER: Chester Village West set on 55 acres with 105 cottages and apartments was purchased by Masonicare, based in Wallingford, the state’s largest…

ACA Mandate Gone, State Eyes Imposing Its Own

cadeuces obamacare2
By: Ana Radelat | ctmirror.com Washington – As Congress is about to vote on a tax overhaul that will gut the Affordable Care Act’s mandate that most…

Access Health projecting 2018 Enrollment Will Match Last Year’s

access Jim Wadleigh 336x252
By: Mackenzie Rigg | CTmirror.com Access Health CEO Jim WadleighKyle Constable / CTMirror.org HARTFORD: With about three weeks left in open…

Feds: State Can Impose Work Requirement for Medicaid Recipients

Seema Verma 771x389
Medicaid chief: Feds are willing to approve work requirements By: Phil Galewitz | Kaiser Health News | Seema Verma, head of the Centers for Medicare…

Technology

New Crowdfunding and Crowdsourcing Ecosystem Helps Test Ideas, Hire…

logan2
Logan: "Entrepreneurs can do more than offer rewards to backers." PLANTSVILLE: Two Connecticut entrepreneurs are taking on the crowd funding and…

Tech Company Hopes To Disrupt CT Real Estate Market

redfin
FAIRFIELD: Connecticut has a new real estate company that is hoping that their expertise in software and digital marketing will allow them to disrupt…

New Haven's New Tech District Is Right Around The Corner

south side view district rendering preview
By Mitchell Young NEW HAVEN: In December 2014, digital media entrepreneurs David Salinas and Peter Sena founders of Digital Surgeons a New Haven…

Nigerian National Pleads Guilty in E-Mail Scheme Defrauding Connecticut…

Email Scams
NEW HAVEN: John H. Durham, United States Attorney for the District of Connecticut, and Patricia M. Ferrick, Special Agent in Charge of the New Haven…

Two Fast Growing Bank Service Companies Set Joint Marketing Plan

cococ
Leaders in Core and Compliance Management Services Working Together to Expand the Deployment of the Unified Compliance Management Model in the…

Datto Founder Donates $50 Million to Alma Mater

profile mcchord
STAMFORD: Austin McChord, founder and CEO of Datto, one of Connecticut’s fastest growing tech companies has donated $50 million to the Rochester…

Glastonbury Financial Service Company Raises $6 Million From Strategic…

payrailz
GLASTONBURY: Payrailz, a digital payments company offering advanced bill payment and money transfer solutions to banks and credit unions, announces…

FuelCell Energy and Toyota Announce Renewable Transportation Fuel Project

Toyota FCHT 5a 1200x801
DANBURY: Some good news comes to Fuel Cell Energy [NASDAQ: FCEL] with an agreement with Toyota to purchase hydrogen for vehicle refueling at the Port…

UCONN Incubation Companies Exceed Funding Target

TIP2017FundingTestTube
STORRS: UCONN Technology Incubation Program companies have raised $54 million in financing in 2017, exceeding the programs $50 million goal and…

New Haven Company Raises $18 Million for Next Generation Computer Tech

QCI Logo
NEW HAVEN: Two seasoned Venture investors have led an $18 million Series A investment into New Haven Quantum Circuits Inc [QCI] The new funds came…

Real Estate & Construction

New Haven’s Vacant Class A Space Overhangs The City

NewHavenSkyline 2
NEW HAVEN: According to the most recent research report for New Haven from Colliers International the New Haven office market is undergoing a change.…

Bristol Myers Campus Sold

bms building
WALLINGFORD: Massachusetts-based , Calare Properties, real estate development company firm has purchased the Bristol-Myers Squibb property for $5…

Mass Mutual To Close Enfield Location and Consolidate In Springfield and…

ENFIELD exterior JUNE2014
After $38 million in improvements just three years ago Mass Mutual is leaving its Enfield location and consolidating operations across the border in…

Former Stanley Office Building Hits Market For Sale

stanleybuilding
NEW BRITAIN: - The former Stanley Black & Decker building at 480 Myrtle Street is for sale. According to Frank Amodio, owner of Amodio & Co. Real…

Concrete Builders Seek To Cement Their Message

concrete truck
WETHERSFIELD: Connecticut Ready Mixed Concrete Association’s [CRMCA] Build with Strength Committee, announced that the CRMCA will be marketing a…

December Home Sales Plummet

house price decline1
BOSTON: 2017 was an excellent year for single family home sales in Connecticut with the year over year sales reaching an eleven-year high. December…

Apartments To Rise At Former Corporate Headquarters' Site

100oak920x920
TRUMBULL: An empty 78,692 square foot office building on 10.78 acres at 100 Oakview Drive will be demolished to make way for a new $30 million rental…

Trucking Company Rolls Into Plainfield

Screen Shot 2018 01 23 at 10.22.28 PM
PLAINFIELD:, CT Truckload carrier Western Express has purchased a 12.85-acre facility at 1293 Norwich Road for $1.75 million. Ron Lyman, CCIM, CEO of…

Stratford Promotion Company Relocating to West Haven

45railroadave
WEST HAVEN: A 24,317 SF light Industrial / Flex building on 1.25 acres located across from the Metro-North West Haven train station at 45 Railroad…

Tech Company Hopes To Disrupt CT Real Estate Market

redfin
FAIRFIELD: Connecticut has a new real estate company that is hoping that their expertise in software and digital marketing will allow them to disrupt…

Government

Anti-Marijuana Organization Cites Potential Costs to Legalization

nomarijuana
HARTFORD: While Advocates for legalization of recreational use of Marijuana in Connecticut cite economic benefit to the state an anti-legalization…

Advocates for marijuana sales point to big economic boost

marijuana
By: Keith M. Phaneuf |ctmirror.org Advocates for legalizing recreational marijuana use in Connecticut — and taxing its sales — are hoping a holistic,…

Fairness to Governor May Come At Expense of Business

Malloy CROP
Hartford: Governor Dannel Malloy thinks the Federal government has been so good to business that a little more tax coming their way is just fine.…

Poll Reveals What Nutmeggers Want

face sad 512
FAIRFIELD: A new survey reports what most Connecticut residents feel about the state of the state. Sacred Heart University’s Institute for Public…

Federal Reserve Program Sends Grants to Ten Connecticut Cities

1200px Federal Reserve from South Boston
BOSTON: Concern about the Federal Reserve raising interest rates in the face of good economic news may have sent the stock market reeling, but ten…

Tesla Revs Up For Another Pass On Direct Selling

Tesla Model 3 shiny CleanTechnica EV Report 2017
HARTFORD: Tesla is looking to a new legislative session in their effort to enable its “direct-to-consumer business model” and sell its electric cars…

Malloy Seeks Tolls, Gas-tax Hike to Rebuild Transportation Network

train
By: Keith M. Phaneuf ctmirror.org Gov. Dannel P. Malloy will ask legislators this year to establish electronic tolling on Connecticut highways by…

Klarides: Will Not Run for Governor

klarides
By: MARK PAZNIOKAS ctmirror.org House Minority Leader Themis Klarides, R-Derby, ended months of speculation about her political ambitions Wednesday,…

Internal Investigation, Lawsuits, Management Changes, A Failed Clinical Trial and New Competition, Heighten Speculation About the Future.

AlexionHQWinter2016NEW HAVEN: The Elm City’s new flagship company Alexion Pharmaceuticals [NASDAQ: ALXN] is finding itself under the microscope of lawyers, financial regulators, investment bankers and even bio-scientists as it reacts to significant financial and drug discovery events in the past 30 days.

In late November, the company announced an internal investigation into sales practices of its main revenue producing drug, Soliris. To date Soliris, with 2015 revenues of 2.5 billion has been the company’s sole financial driver.

The company’s stock trading was frozen for a short period as it declined to release its 10Q report on time. The company did file in early January stating there was no need for any material changes to its previous filings or restatements.  How that plays out with the lawsuits and whether it puts the issue to bed remains to be seen. Company analysts have said that whistleblower claims at big companies have become more common and part of the investment landscape. A 10Q report however, requires senior management to personally certify, in writing and under oath the accuracy of a company’s financial information.

What the company did release very quickly,surprising investors and analysts, were CEO David Hallal and CFO Vikhas Sinha who would have had to sign the 10Q.

Officially the company said Hallal was leaving for “personal” reasons and Sinha to pursue “other opportunities.” The investment news website Seeking Alpha however, argued that the pair was avoiding the filing responsibility under federal law [Sarbanes Oxley] to certify the report. It added that, “Alexion implied the executives departed due to the company having lost confidence in them.” 

Hallal took over from Alexion founder David Bell in April 2015, Bell remained as Chairman of the Board. An Alexion board member since July 2014

david brennan splash
New CEO Brennan

a former Astrazeneca [NYSE: AZN] CEO David Brennan, was chosen to “temporarily” take the position of CEO and headhunting firm Spencer Stuart was tapped to find a permanent replacement.  Former Honeywell International [NYSE:HON] CFO David Anderson was chosen as the company’s new CFO.  Brennan signed the 10Q certifying its statements.

Two investor class action lawsuits have already been filed against the company and several law firms across the country are seeking claimants. Building a class of disgruntled stockholders to join in, won’t likely prove a difficult task.

In early December, Alexion stock tumbled to $113 per share, its lowest level in three years. The company’s stock’s price however, had already come down along with many bioscience stocks from their 2016 highs, Alexion’s 52 week high was $193
per share. 

Two newly approved drugs are expected to fortify the company’s sales pipeline. The integration of its acquisition for $8.4 billion in June 2015 of Synageva of Lexington, MA, brought  the drug Kanuma and a previous acquisition in 2012 of Enobia of Montreal, Canada for $610 million brought the drug Strensiq.  Both drugs were approved by the FDA in late 2015 and like Soliris, treat rare diseases where there are no other current drug treatments.

Kanuma treats Lysosomal Acid Lipase Deficiency, [LAL Deficiency], a disease that prevents the body from adequately disposing of fatty acids. Leading to problems in the liver, spleen, and blood vessels. Stensiq treats Perinatal, Infantile and Juvenile-onset Hypophosphatasia (HPP),  an inherited rare metabolic bone disease that disrupts bone mineralization. Symptoms include weakening and softening of the bones that cause skeletal abnormalities. Hypophosphatasia affects an estimated 1 in 100,000 newborns.

The market for the two acquired drugs is estimated to have a potential of nearly $1.7 billion annually. They are off reportedly off to a slow start however. After a year plus on the market sales of the two are expected to be less than $200 million so far.

With new drugs coming on line, things started out pretty rosy in 2016 with the company moving into a new global corporate headquarters in downtown New Haven. Initially the company considered that 400-600 employees would occupy its new tower, 1,000 are said to be already there. The company has told the city to expect as many as 1,700 jobs could come to New Haven.

The original allegation about the Soliris sales practices was raised by a former employee of the company. 

The “listed” price of the drug for an annual treatment is currently approximately $450,000 per year, but the company offers a variety of methods to reduce that cost, including grants where necessary for patients. One explanation floated about the investigation revolved around how the company treated booking grants for the drug.

Alexion has been seeking new uses for Soliris and just received some bad news in that arena too.  Results from a Phase 2/3 trial of eculizumab (Soliris) showed “the drug failed to reach its primary endpoint for the prevention of delayed graft function in recipients of deceased donor kidneys.” There were no previously available treatments for this condition that can cause the loss of a transplanted kidney.

Competitors for Soliris have also begun to rise with their own clinical results coming in the most recent quarter. Alnylam Pharmaceuticals [Nasdaq:ALNY] of Cambridge, MA is a $3.5 billion market cap company that is developing a drug using RNA gene splitting technology, if successful their drug would compete directly against Soliris. The company said results from a Phase 1/2 trial when used with Soliris showed safety and improvements for patients and the need of less Soliris. That drug is still at least a Phase 3 trial success and FDA approvals down the road.

A smaller biotech Seattle’s Omeros  [NASDAQ: OMER] with less than a half billion dollar market cap just announced the FDA is signing off on the company’s plans for clinical development and manufacturing of another competing drug. The company is seeking accelerated approval, claiming it believes it has demonstrated “clinical advantages over Soliris.”

To qualify for accelerated approval, a drug must treat a serious condition and generally provide a ‘meaningful advantage’ over available therapies, the Omeros’ drug has already been tested in Phase 2 studies. 

The even smaller Akari Therapeutics [NASDAQ:AKTX] based in London with only a $87 million market cap is another competitor with a drug [Coversin] trying to close in on Soliris.  Akari’s drug is derived from a protein produced by ticks. Akari claims it targets the same body chemistry as Soliris and that side effects are minimal. Coversin is taken orally, while Soliris is infused weekly. Akari expects to move into Phase 3 trials of Coversin in 2017.

For several years Alexion has been
rumored to be a target for acquisition from a larger pharmaceutical company. The industry has been driven by consolidation fueled by an expected push back from government over pricing, and the need to obtain more scale to deal with the increasing costs of drug development. 

The acquisition target theory circulated on investment news media goes that most of the big fish are already taken in the “pharma space” or would receive a hostile response from governments in the US and Europe.

Alexion is by no means a giant, but with its approximate $30 billion market cap, and a currently captive market, it remains a potentially juicy target.

The alternate argument has been that big pharma companies don’t want orphan drugs that treat fewer than a few hundred thousand patients worldwide. Making the case harder, Alexion stock trading at 15 times sales was too overpriced for the “street.”

Be that as it may, the Streetinsider.com  a reliable investment news source reported in early December that Alexion “was approached by a large U.S.-based drug company interested in a merger, according to a person claiming to have knowledge of the matter. The name of the suitor wasn’t made available.” 

The site continued with, “a number of large U.S. and foreign players are known to be shopping for drugs large enough to move the needle on revenue, and slightly troubled companies like Alexion probably aren’t being ruled out.”

Alexion has not responded to the rumor.