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KMDA

Kamada

$5.20

-0.05 (-0.95%)

, SHPG

Shire

$156.86

-0.43 (-0.27%)

07:02
01/08/18
01/08
07:02
01/08/18
07:02

Kamada announces interim results from Phase 2 clinical trial of IV AAT

Kamada (KMDA) announced interim results from the company's Phase 2 trial of intravenous Alpha-1 Antitrypsin, or IV AAT, for the prevention of lung transplant rejection. The study is being conducted in collaboration with Shire (SHPG) at the Rabin Medical Center - Beilinson Hospital in Israel, and is being led by Prof. Mordechai R. Kramer, M.D., Director of the Institute of Pulmonary Medicine at the Hospital. The Phase 2 trial is a randomized, open-label study of 30 lung transplant patients to evaluate the safety and efficacy of IV AAT to prevent lung transplantation rejection compared with standard-of-care treatment, or SOC. The study is randomized 2:1, with 20 patients in the treatment group receiving IV AAT in combination with SOC, or AAT+SOC, and 10 patients in the control group receiving SOC. This is a two-year study, with the first year consisting of an evaluation of treatment with AAT+SOC vs. SOC, and then an additional one-year of follow-up. In May 2017, the last of the 30 patients to be recruited entered the study and began treatment. The interim report summarizes data from the first six months of treatment for the initial 16 patients in the study. Ten of these 16 patients are in the AAT+SOC group, and six are in the SOC arm. To date, six patients have died, four patients in the AAT+SOC arm, and two in the SOC group, from common transplant-related complications unrelated to treatment with IV AAT. Out of the 10 total patients who lived throughout the six-month treatment period, four experienced acute rejection post transplantation, but survived and their situation improved and stabilized. Two of the patients who experienced the acute rejections were in the AAT+SOC arm, but their situation resolved without the need to change treatment; the other two patients were in the SOC group and their situation resolved, with one of them changing treatment. Moreover, pulmonary function, which is a key indicator of acute or chronic rejection, improved and was found to be stable in all 10 patients who are alive following six months of treatment. Kamada's IV AAT demonstrated a favorable safety and tolerability profile, consistent with the results observed in previous clinical studies in different indications. None of the adverse events, or AEs, or serious adverse events, or SAEs, observed to date were considered to be related to treatment with IV AAT. During the six months of treatment, the six patients in the SOC group had a total of 28 AEs, while the 10 patients in the AAT+SOC arm had a total of 36 AEs. This represents a rate of 3.6 AEs and 2.5 AEs per 100 days of treatment in the SOC and AAT+SOC arms, respectively. Out of the 28 AEs in the SOC group, four were SAEs, while out of the 36 AEs in the AAT+SOC arm, three were SAEs. This represents a rate of 0.51 SAEs and 0.2 SAEs per 100 days of treatment in the SOC and AAT+SOC arms, respectively.

KMDA

Kamada

$5.20

-0.05 (-0.95%)

SHPG

Shire

$156.86

-0.43 (-0.27%)

  • 08

    Jan

  • 08

    Jan

  • 26

    Feb

  • 25

    Mar

KMDA Kamada
$5.20

-0.05 (-0.95%)

SHPG Shire
$156.86

-0.43 (-0.27%)

11/16/17
CANT
11/16/17
NO CHANGE
Target $222
CANT
Overweight
Roche's black box warning positive for Shire, says Cantor Fitzgerald
Cantor Fitzgerald analyst Louise Chen says the black box warning put on Roche's (RHHBY) Hemlibra by the FDA is a positive for Shire (SHPGY). The analyst believes the news supports her belief that concerns about competition for Shire's hemophilia franchise are overdone. Chen keeps an Overweight rating on Shire with a $222 price target. The stock in afternoon trading is up 4% to $146.13.
11/20/17
BTIG
11/20/17
NO CHANGE
Target $242
BTIG
Buy
Shire selloff on Roche news seems overdone, says BTIG
BTIG analyst Timothy Chiang said today's weakness in Shire (SHPG) shares is overdone and creates a potential buying opportunity. While Roche's (RHBBY) emicizumab is likely to gain share at the expense of Shire's Advate, he does not expect a rapid conversion and thinks Shire's pipeline and platform seem overly discounted at current levels. Chiang has a Buy rating and $242 price target on Shire shares.
11/20/17
DBAB
11/20/17
NO CHANGE
Target $53
DBAB
Hold
Deutsche cuts Bioverativ target to $53 after positive Roche data
Deutsche Bank analyst Andrew Peters lowered his price target for Bioverativ (BIVV) to $53 from $65 and remains cautious on the shares following today's positive data from Roche's (RHHBY) Phase 3 study evaluating Hemlibra in noninhibitor hemophilia A patients. While full data is needed to better understand the clinical and competitive profile, the data reported today suggest Hemlibra will likely pressure the longevity and sustainability of Bioverativ's Eloctate franchise, Peters told investors earlier in a research note. The analyst reiterated a Hold rating on Bioverativ shares. The stock closed the trading day down 9.5% to $50.76. Shire (SHPG), another company with a hemophilia franchise, closed today down 4% to $141.37 while Roche rallied 6% to $30.82.
01/05/18
COWN
01/05/18
NO CHANGE
Target $225
COWN
Outperform
Cowen buyers of Shire on any weakness
Cowen analyst Ken Cacciatore believes Shire's Hemlibra risks are well understood, but he said many components of the business, mainly its immunology segment, are underappreciated. The analyst continues to believe the reality of the competitive launch will unlikely match the fear and so recommends buying the shares on any weakness. Cacciatore reiterated his Outperform rating and $225 price target on Shire shares.

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